Fiscal Year 2001 Annual Report

Diabetes Mellitus 

Interagency

Coordinating Committee
CONTENTS

Introduction

Activities of Member Organizations 1

National Diabetes Education Program 45

Meeting Summaries 51

Appendix A: Public Health Service Act 91

Appendix B: DMICC Roster 93

Diabetes Mellitus 

Interagency 

Coordinating Committee
INTRODUCTION

In accordance with Section 429 of the Public Health Act, the Diabetes Mellitus Interagency Coordinating

Committee (DMICC) prepares an annual summary report of its activities as well as other Federal research 

activities in the field of diabetes. It is submitted to the Secretary, Department of Health and Human Services

(DHHS), and the Director of the National Institutes of Health (NIH). This is the annual report of the DMICC 

for Fiscal Year (FY) 2000.

LEGISLATIVE MANDATE

The DMICC was authorized by Public Law 93-354 and established in fall 1974; subsequent legislation modified

some of the charges to the Committee. The legislative authority of the Committee is presented in Appendix A.

The charge to the DMICC is to coordinate the research activities of the NIH and other Federal agencies relating 

to diabetes mellitus and its complications and to contribute to the adequacy and technical soundness of these

activities by providing a forum for communication and exchange of information.

The Committee includes representatives from Federal agencies whose programs are relevant to diabetes 

mellitus and its complications. The chairman, designated by the Director, NIH, is the Director, Division of

Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney

Diseases (NIDDK). In FY 2000, the DMICC membership included representatives of 21 Federal organizations.

A roster of Committee members as of the close of the fiscal year is included as Appendix B.

ACTIVITIES OF THE DMICC

The DMICC facilitates cooperation, communication, and collaboration among agencies that conduct or support

diabetes-related activities. These activities may range from support for biomedical research to direct provision of

health care services. The DMICC provides both a forum for initiating interactions and a mechanism for 

tracking progress.
ACTIVITIES OF MEMBER ORGANIZATIONS
DMICC ANNUAL REPORT 3 FY 2001

Agency for Healthcare Research and Quality

(AHRQ)

The Agency for Healthcare Research and Quality 

continues to be involved in a broad range of activities

related to improving the quality of health care,reducing its costs, improving patient safety, decreasing

medical errors, and broadening access to essential

services related to diabetes. These activities include

the support of research and collaborations with 

others in the public and private sectors to improve

outcomes for those with diabetes and to prevent the

condition across the population.

Current Activities

The Agency is funding and involved with a large

number of studies related to diabetes. A number of

recent RFAs (Requests for Applications) have specifically identified diabetes as a priority condition.

These RFAs include one focused on the translation of

research into practice (TRIP II) and one aimed at

establishing Excellence Centers to Eliminate

Ethnic/Racial Disparities (EXCEED). Under these initiatives, researchers are examining why disparities

exist in the care and outcomes of minorities with

diabetes and what can be done to reduce or eliminate

these disparities. Projects include an examination of

the association between diabetes education programs

and quality of care indicators in the Indian Health

Service; implementation of successful managed care

models of diabetes care in underserved populations;

a community-based participatory research study to

improve processes of care for elderly AfricanAmerican diabetics; an evaluation of the impact of

point-of-service testing of Hemoglobin A1c on care

and outcomes; and the development and evaluation

of a culturally sensitive multimedia education program aimed at increasing diabetes-related knowledge, self-efficacy, and self-care for African-American

and Latino populations. Other studies that are being

funded include an assessment of diabetes care in

community health centers, the effects of Navajo

interpreters on diabetes outcomes, the effectiveness

of an automated telephone disease-management 

system for English- and Spanish-speaking patients,

and an evaluation of the impact on utilization and

outcomes of changes in managed care policy toward

reimbursement for glucose self-monitoring.

Staff at AHRQ are also involved in a number of intramural studies of diabetes. Investigators are using

data from the Medical Expenditure Panel Survey

(MEPS) to develop national estimates for medical 

visits, individual expenditures, and sources of payment for people with diabetes. Another group is

studying factors associated with multiple hospitalizations of diabetics.

AHRQ continues to work with individuals and organizations to ensure that the evidence-base is being

employed. The Office for Health Care Information has

recently released two syntheses presenting findings

from AHRQ-supported research on diabetes and on

racial and ethnic disparities in diabetes.

The Diabetes Quality Improvement Project (DQIP),

based in large part on the AHRQ-supported Diabetes

Patient Outcomes Research Team (PORT), is a 

collaboration of AHRQ with the Centers for Medicare 

and Medicaid Services (CMS), the National Committee 

for Quality Assurance, the Department of Veterans

Affairs, the American Diabetes Association, and 

others. It continues to develop core measures of diabetes performance that allow benchmarking across

organizations and identify opportunities for improvement among health plans and providers. Reporting

on DQIP measures is now required of managed care

organizations by CMS and results will be made 

publicly available.

ACTIVITIES OF MEMBER ORGANIZATIONS
DMICC ANNUAL REPORT 4 FY 2001

AHRQ is also collaborating with the Juvenile

Diabetes Research Foundation International and

other private and public sector partners in efforts to

improve rates of screening and treatment fordiabetes

retinopathy.

Future Activities

Much of the work mentioned above will continue during the next fiscal year. It is expected that additional

work will be funded under the agency’s program

announcements (PAs) and RFAs. Specifically, the PA

calling for applications to enhance the evidence on

patient-centered care is aimed at chronic conditions

including diabetes.

Center for Scientific Review (CSR)

The Center for Scientific Review is a center within 

the National Institutes of Health, where a majority 

of investigator-initiated applications in diabetes and

obesity areas are reviewed. The mechanisms of application support are the investigator-initiated individual project applications (R01s), High Risk/High

Impact Pilot grant applications (R21s), Small

Business Investment Research Applications or

Technology Transfer (SBIR/STTR,) and Individual

Fellowship Applications: Predoctoral (F31)

Postdoctoral (F32) 

and Senior Fellowships(F33).

Thus, the mission of CSR relevant to activities of

DMICC is central and pivotal through help in maintaining the quality of diabetes and obesity research

in the nation. The knowledge gained through these

NIH-supported projects would help control/treat type

1 diabetes and type 2 diabetes and obesity in areas

of the world where these endocrine and metabolic

disorders are prevalent.

Current Activities

Under the above research support application mechanisms, pertinent areas that are covered fall into two

main categories: Basic and Clinical Research. Areas

include: Beta Cell Biology, Islet and Pancreas Transplantation, Insulin Action , Insulin Resistance, Pathogenesis of Type 1 and Type 2 Diabetes, and also the study

of pathogenesis of obesity.These studies invoke molecular genetic, metabolic, and histochemical approaches.

These applications are reviewed in several Scientific

Review Groups(SRGs) within which individual subcommittees are located. Each of these subcommittees

(study sections) has definite expertise to review 

specific areas relevant to diabetes and obesity.

Centers for Disease Control and Prevention (CDC)

The mission of CDC’s diabetes programs is to document and reduce the burden of diabetes through

public health action. This mission is directed to all

populations within the United States and associated

territories and consists of surveillance and epidemiology science; health services research; populationbased diabetes control programs; and translation

efforts that convert important diabetes research 

findings into clinical and public health programs.

Current Activities

• National and territorial surveillance activities 

for diabetes and associated complications, with 

public health programs in all 50 States, the U. S.

territories, and the District of Columbia.
DMICC ANNUAL REPORT 5 FY 2001

• Targeted surveillance and epidemiologic programs

that focus on youth with diabetes (type 1 and type

2), ethnic and racial minority communities, women

with or at risk for diabetes, and members of managed care organizations.

• Health services and economic research, including

evaluation of the structure and function of managed care organizations within the United States

and cost-effectiveness analyses of diabetes, associated complications, and preventive treatment.

• Expansion of State-based Diabetes Control

Programs (DCPs) to include surveillance activities,

programs that target high-risk ethnic and racial

minority communities, and State/territorial policies

that facilitate/impair diabetes prevention programs.

• Partnerships with Federal and State-based diabetes

organizations (e.g., with National Institutes of

Health through the National Diabetes Education

Program, Health Services and Resources Administration (HRSA) through the Diabetes Collaborative,

Indian Health Service through the National

Diabetes Prevention Center; and others) as well 

as the private sector (e.g., Washington Business

Group on Health, American Association of Health

Plans, and others).

Major Accomplishments in FY 2001

Diabetes Burden in the United States. CDC validated

and published surveillance information regarding 

the past, present, and future burden of diabetes

prevalence through use of the Behavioral Risk Factor

Surveillance System (BRFSS) and computer modeling,

documenting the dramatic and disconcerting

increase in type 2 diabetes, in association with

increasing obesity and decreasing physical activity.

Programs Addressing Diabetes in Special

Populations. The agency implemented several scientific and programmatic activities that specifically 

target special populations, including:

• Youth With Diabetes: through the SEARCH project,

established six (6) regional sites that have created

registries for prevalence and incidence of diabetes

among youth (< 20), as well as quality of care.

• Women With/At Risk for Diabetes: established a

public health initiative to address social, economic,

and cultural barriers to diabetes prevention and

management among all women across the 

life-spectrum.

• Solidified and implemented programs that address

a public health program for all American Indians

with the National Diabetes Prevention Center in

Gallup, New Mexico.

• Expanded interactions among public health (Statebased DCPs) and clinical programs (Community

Health Centers (CHCs)/HRSA) to improve the “safety

net” for disadvantaged persons with diabetes to >

400 CHCs and > 40 DCPs.

Diabetes in Managed Care. CDC finalized data 

collection procedures and initiated information 

accumulation for diabetes preventive care practices

and outcomes among large managed care organizations within the United States through the TRIAD

(Translating Research Into Action for Diabetes)

Project.

Economic Dimensions of Diabetes. CDC initiated 

economic analyses of primary prevention of type 2

diabetes, interventions to prevent diabetic renal 

disease, and preventive strategies to reduce the 

incidence and seriousness of cardiovascular disease

(CVD) among persons with diabetes.
DMICC ANNUAL REPORT 6 FY 2001

Future Activities

• Develop “Action Plan” for the Public Health

Initiative on Women with Diabetes.

• Develop strategies and programs that address 

primary prevention for type 2 diabetes, including

screening, economic, and public health interventions with CDC’s projects.

• Expand surveillance activities that address health

disparities, quality of life dimensions to the diabetes burden, and economic aspects of diabetes.

• Through the National Diabetes Education Program,

expand broad-based activities that address cardiovascular disease among persons with diabetes, as

well as initiate science-based interventions to

improve primary prevention for type 2 diabetes.

• Expand the programs of the State-based DCPs 

so that adequate support and advice would be 

provided to all programs.

Centers for Medicare & Medicaid Services 

(CMS) [formerly HCFA] 

Diabetes activities at CMS in 2001 fell into several

broad categories: evaluation of the quality of care

provided to Medicare beneficiaries, national and

State-level quality improvement projects designed to

improve care for Medicare beneficiaries; reimbursement and coverage policies to support quality care;

beneficiary educational campaigns; and research to

support quality diabetes care.

Current Activities

Evaluation of quality of care provided to Medicare

beneficiaries was conducted for beneficiaries in both

Medicare fee-for-service and in managed care. These

data, based on the Diabetes Quality Improvement

Project (DQIP), a project initiated and funded by 

CMS, allow identification of opportunities for

improvement and focus for quality improvement

projects. A Medicare quality surveillance system 

was developed in 2001 that will allow ongoing

assessment of the characteristics of beneficiaries

with diabetes, quality of care and outcomes of care

for diabetes, and monitoring of the impact of key 

regulations and coverage decisions.

National and State-level quality improvement 

projects included the National Eye Project to improve

eye exam rates in conjunction with the American

Academy of Ophthalmology and the American

Optometric Association. All Medicare managed care

plans were required to conduct quality improvement

activities in diabetes. State-level efforts conducted by

Quality Improvement Organizations in collaboration

with individual practitioners, medical specialty

groups, and other partners occurred in all 50 States

and three territories. In the fee-for-service setting,

remeasurement demonstrated significant improvement of quality during the time period during which

these efforts were implemented (ranging from a 3

percent increase in eye exam rates to a 15 percent

increase in lipid testing). Improvements in quality of

diabetes care in Medicare managed care plans were

also impressive.

Payment and coverage policies to support quality

care included publication of the final regulations

about the diabetes self-management training benefit

authorized under the Balanced Budget Act of 1997.

Regulations governing the new medical nutrition

benefit for patients with diabetes or renal disease

were also published and the benefit will go into

effect on January 1, 2002.
DMICC ANNUAL REPORT 7 FY 2001

Two new coverage policies were announced. The first

modified the coverage requirements for use of a 

subcutaneous insulin pump to broaden eligibility to

include more persons with type 1 and some with

type 2 diabetes. The second policy will reimburse

providers for beneficiaries with diabetes and diabetic

peripheral neuropathy with loss of protective sensation to have up to two foot exams per year.

Beneficiary education campaigns in 2001 attempted

to encourage beneficiaries to control their blood

sugar and publicized the expanded Medicare benefit

for blood sugar management. Over 3.2 million people

were reached via print media and 2.2 million people

via television campaigns. A new campaign for 2002,

in conjunction with the National Diabetes Education

Program, entitled “Be Smart About Your Heart:

Control the ABCs of Diabetes” will build on the successes of the “Power to Control Diabetes is in Your

Hands” campaign launched in 2001 and will further

promote the new diabetes self-management training

benefit and the nutrition therapy benefit and educate

older adults about the high risk of heart attack or

stroke if they have diabetes. An upcoming campaign

in conjunction with the National Institutes of

Health’s National Eye Institute will promote the new

Medicare benefit for glaucoma detection that will

provide coverage for an annual dilated eye exam for

Medicare beneficiaries at high risk for glaucoma

(including those with diabetes).

Research to support quality diabetes care has

included examination of the factors in both the feefor-service environments and in managed care plans

that influence quality. For example, there are significant relationships between rates of eye exams and

the proportion of plan members who have a personal

physician. Another research project underway in 2001

is exploring characteristics and systems in place in

managed care plans consistently reporting the highest quality diabetes care.

Food and Drug Administration (FDA)

FDA is charged to approve safe and efficacious

agents for public use. This is especially important

with regard to therapeutic agents in the treatment 

of diabetes mellitus.

Current Activities

Insulin resistance is the hallmark of type 2 diabetes.

A new class of insulin-sensitizing agents, the thiazolidinediones, decrease hyperinsulinemia by alleviating insulin resistance. Troglitazone, the prototype,

had been approved and withdrawn from the market

due to liver toxicity. Two newer members of the thiazolidinedione class have since been approved—

rosiglitazone in May and pioglitazone in July 1999.

Careful monitoring for possible hepatic adverse

effects are being followed as for troglitazone.

Numerous clinical trials are now reporting multiple

cardiovascular benefits of this class of agents, which

decrease hyperinsulinemia by alleviating insulin

resistance.

Other non-thiazolidinedione peroxisome proliferatoractivated receptor (PPAR) dual agonists, active at

both alpha and gamma PPAR receptors, are being

developed by various pharmaceutical companies.

Currently, there are more than a dozen such agents 

in various phases of the drug development process.

They have been demonstrated to have both glucose

and lipid lowering activities.

Lantus (insulin glargine (rDNA origin)) was approved

this year for adult patients with type 2 diabetes and

pediatric patients (> 6 years of age) with type 1 diabetes. This insulin analog provides 24-hour basal

glucose-lowering activity. Lantus insulin must not be

diluted or mixed with any other insulin or solution.

NovoLog Mix 30/70 was also approved. This insulin

preparation may provide adequate glucose control

with one shot daily.
DMICC ANNUAL REPORT 8 FY 2001

Health Care Financing Administration (HCFA) 

See Centers for Medicare & Medicaid Services

(CMS)

Health Resources and Services Administration

(HRSA)

The Health Resources and Services Administration

manages several health care systems programs that

include diabetes identification, education, prevention,

or treatment.

Current Activities

Bureau of Primary Health Care. HRSA’s Bureau 

of Primary Health Care (BPHC) established two 

strategic goals: to move toward the elimination of

health disparities and toward a 100 percent access

system for all Americans. The Health Disparities

Collaboratives, started in FY 1999, seeks to (1) 

generate and document improved health outcomes

for underserved populations, (2) transform clinical 

practice through new models of care, (3) develop

infrastructure, expertise, and multidisciplinary 

leadership to improve health status, and (4) build

strategic partnerships.

The initiative originally focused on diabetes mellitus—to delay or decrease disease complications—by

implementing an evidence- and population-based

model of care, which relies on knowing which

patients have the illness and helps them participate

in their own care. It has six basic elements: support

of patient self-management, clinical decisions support, delivery system redesign, a clinical information

system, organization of health care, and strong partnerships with local government and community

organizations.

BPHC activities include:

• A total of 270 health centers participated in the 

initial year-long diabetes collaboratives. Eightyeight centers in 1999, 118 centers in 2000, and 62

centers are currently participating in the Diabetes 

3 Collaborative.

• After completing the year-long collaborative, health

centers continue to receive support to promote the

model of care throughout their organizations, bring

change to clinics, and measure its impact on the

health of underserved patients.

• Orientation and training videos and a brochure

describe the initiative.

• A software program was developed to meet the

need for a comprehensive clinical information system. It combines patient information management

of diabetes with the comorbidity of cardiovascular

disease by looking at multiple disease registries.

• Depression screening is included in the care of 

diabetes patients.

• Partnerships with other Federal agencies, State 

diabetes control programs, and private-sector

organizations continue to grow stronger.

BPHC outcomes include:

• Health centers continue to report on the shared 

key goal that 90 percent of patients with diabetes

will receive two HbA1c tests annually, at least 3

months apart. Starting in 2000, a shared health outcome measure was added to all the collaboratives

(Diabetes 1, Diabetes 2, and Diabetes 3 collaborative participants) requiring them to report on 

control of glucose levels (average HbA1c) and a 

self-management support measure. Additional

measures focus on prevention of cardiac as well as

microvascular complications, the latter including

eye, kidney, and lower extremity disease.
DMICC ANNUAL REPORT 9 FY 2001

• There are over 41,000 persons with diabetes in 

electronic registries that enable centers to track

and manage the health of these patients.

• The average HbA1c has decreased from 9.2 to 8.5

for more than 12,200 patients in the Diabetes 1

Collaborative.

• The average HbA1c has decreased from 8.9 to 8.3

for more than 22,000 patients in the Diabetes 2

Collaborative.

• Average percentage of patients with two HbA1c

tests in 12 months increased from 24 percent to 

48 percent in Diabetes 1 and 2 Collaboratives as

they disseminated the care model throughout the 

organization and the registry size grew.

• Forty percent (40%) of patients have documented

collaboratively set self-management goals.

BPHC strategic partnerships and infrastructure

development highlights include:

• Six cluster directors and five information systems

specialists are employed by the five lead Primary

Care Associations. Five Sate-based cluster coordinators and two information systems specialists

were added this year to the cluster infrastructure.

• A national BPHC director of the collaboratives

started in April 2000.

• Primary Care-Public Health partnerships are highlighted as a programmatic success. The partnership

with CDC Division of Diabetes Translation continues to be strengthened. In 1999, 15 initial partnerships were established between State health

department Diabetes Control Programs (DCP) and

health centers working on the diabetes collaborative. Direct support to health centers from DCPs

was $1.3 million. In 2000, health centers received

$2.7 million in support.

• The Agency for Health Research and Quality is

assisting with the program evaluation strategy.

Maternal and Child Health Bureau. The Maternal

and Child Health Bureau (MCHB) administers maternal and child health (MCH) Block Grants to States 

to support programs that promote the health of all

the Nation’s mothers and children and ensure

statewide systems of health care for the MCH population. Diabetes screening, education, prevention,

and treatment programs may be supported under

these grants.

Additional Title V activities, such as MCH research,

training, genetic services, and MCH improvement

projects, are supported under Special Projects of

Regional and National Significance. While these

activities may not specifically target Diabetes

Mellitus, core elements of community systems of

care serving children with special health care needs

are addressed. MCHB, in concert with the March of

Dimes, the American Academy of Pediatrics, and

Family Voices, has developed a 10-Year Action Plan to

achieve community-based systems for children and

youth with special health care needs and their families, including children with diabetes. The Healthy

Start Initiative to significantly reduce infant mortality in targeted communities also includes services

addressing diabetes in mothers and children. In

addition, MCHB promotes diabetes detection and

care through school-based and school-linked 

health programs.

The MCH Training Program provides training grants

to graduate programs and professional schools to

support teaching, research, and service activities 

that focus on women and children. Its Leadership

Education in Adolescent Health (LEAH), public health

nutrition, and pediatric nutrition grantee programs

include diabetes education. The Eighth Annual

Pediatric Update in May 2001, sponsored by the

Department of Pediatrics at the University of

Alabama at Birmingham, addressed “Type 2 Diabetes

in Children and Youth.” A national videoconference in

September 2001, sponsored by the Indiana University
DMICC ANNUAL REPORT 10 FY 2001

School of Medicine, included an intensive workshop

on “Treatment Challenges for Children and

Adolescents with Type 2 Diabetes.”

Bureau of Health Professions. The Bureau of Health

Professions (BHPr), which provides national leadership in establishing the Nation’s health personnel,

charges its Division of Health Careers Development

to provide technical assistance to community groups

to improve the health status of diverse and disadvantaged populations significantly affected by Diabetes

Mellitus; Type 2 in particular.

Office of Rural Health Policy. The Office of Rural

Health Policy funds approximately 18 grantees

through its Outreach and Network Development program, including a component that addresses the diabetic population. Projects receive 3years of funding—

from approximately $40,000 to $200,000 per year.

Seven projects were funded in 1999, seven in 2000,

and an additional five in 2001. Some focus on the

diagnosis, treatment, education, or prevention, while

others focus on a goal that deals with diabetes.

Projects focusing primarily on diabetes, include:

• The Diabetes Prevention and Care Project, a collaborative effort coordinated and overseen by the

Chiricahua Community Health Center, Elfrida,

Arizona, focuses on the provision of treatment and

education about diabetes for at-risk individuals in

a predominately Hispanic community (68%).

• The Sunset Diabetes Outreach and Education

Project works to improve access to health care 

services for the target population of mostly

Hispanic migrant farm workers and their families

in Yuma County, Arizona.

• The Park County Diabetes Project was established

at Livingston Community Health Care System, Inc.,

in Livingston, Montana, to address the needs of

individuals with diabetes in rural communities.

Office of Special Programs. HRSA has been working

with the Organ Procurement and Transplantation

Network, the national system for matching donated

organs with patients on the transplantation waiting

list, to facilitate the allocation of pancreatic organs

for use in pancreatic islet cell transplants in treating

patients with type I diabetes mellitus. Five transplant centers are now performing islet cell 

transplants.

Indian Health Service (IHS)

The mission of the IHS National Diabetes Program

(NDP) is to develop, document, and sustain a public

health effort to prevent and control diabetes in

American Indian and Alaska Native (AI/AN) people.

The agency promotes collaborative strategies for the

prevention of diabetes and its complications in the

12 IHS Administrative Service Areas through a network of 19 Model Diabetes Programs and 13 Area

Diabetes Consultants. The agency also disseminates

current information about all aspects of diabetes

surveillance, treatment, education, and prevention.

Diabetes was the most frequently identified health

problem in IHS Area consultation workshops for FY

2002 planning. Type 2 diabetes disproportionately

affects AI/AN adults who are over three times more

likely to have diabetes than the general U.S. population. A recent alarming trend is the increase in prevalence of type 2 diabetes in AI/AN young persons. Over

a 9-year period, from 1990–1998, the prevalence of

diabetes rose 68 percent in AI/AN adolescents and

young adults. Recent data show that diabetes mortality is 4.3 times higher in the AI/AN population than

in the U.S. population. There was a 24 percent

increase in the American Indian age-adjusted death

rate from diabetes from 1991–1993 to 2000. There is

clear evidence that for Indian people the health disparity related to diabetes is increasing.
DMICC ANNUAL REPORT 11 FY 2001

Significant Activities in 2001

Special Diabetes Program for Indians, 1997 

Balanced Budget Act and 2001 Consolidated

Appropriations Act. The IHS Diabetes Program

administered Year 4 of the Special Diabetes Program

for Indians of the 1997 Balanced Budget Act (BBA).

Thirty million dollars per year have been distributed

from the BBA funds through 286 non-competitive

grants administered at 318 sites throughout Indian

country. In December 2000, Congress appropriated 

an additional $70 million to the Special Diabetes

Program for Indians through the Consolidated

Appropriations Act of 2001. Over 96 percent of these

funds are distributed through grants to tribes, IHS

facilities, and urban Indian centers while 3.8 percent

are withheld for administration of the grant program.

Tribal entities are the direct recipients of 81 percent

of the grants. The IHS National Diabetes Program

(NDP) works closely with the Tribal Leaders Diabetes

Committee to administer this program. The new

Request for Application developed by the IHS NDP

this year included a Best Practices approach with 14

strategies identified, researched, and compiled for

use by applicants.

IHS Standards of Care & Education; IHS to become a

Deeming Entity for Diabetes Education Certification.

Education Standards. The IHS National Diabetes

Program, with agency and tribal leader support, has

established an Indian Health Diabetes Education

Accreditation Program and has received notification

from the Centers for Medicare and Medicaid Services

(formerly HCFA) that the IHS NDP application to

become a deeming entity will soon be approved. This

process will allow Indian health diabetes education

programs to become certified and thus seek Medicare

reimbursement for diabetes education.

Clinical Standards (Diabetes Care and Outcomes

Audit). The IHS National Diabetes Program updated

the IHS Standards of Care for Diabetes in 2001 to

reflect new science and best practices. The Annual

IHS Diabetes Care and Outcomes Audit, a voluntary

medical records review of 87 clinical care and public

health practices and outcomes, is based on these

standards. These standards and audit summary

results are distributed to providers IHS-wide through

a network of regional Area Diabetes Consultants and

local Diabetes Coordinators and are used as quality

indicators at the local, regional and national levels to

identify specific problems and to determine policy

and practice.

Obesity Prevention. The IHS National Diabetes

Program is coordinating an obesity prevention initiative targeting Head Start children (0–5 years), families, Head Start staff, and AI communities. Five tribal

Head Start pilot sites, in collaboration with their

respective community health partners, have developed obesity and diabetes prevention interventions

in their local communities. Each Head Start site community action plan includes multifaceted program

activities and milestones focusing on healthy eating,

physical activity, healthy behavior, and community

partnerships. The core component of the initiative is

to develop and sustain local community partnerships

in the implementation of each program’s interventions. The five pilot sites are developing outcome

measure and evaluation methods for each of their

individual action plans. The sites evaluate their

progress every 6 months and modify interventions

as appropriate.
DMICC ANNUAL REPORT 12 FY 2001

Joslin Vision Network Teleophthalmology Project.

In FY 2002, Congress increased to $1.5 million the

IHS appropriation to address screening for diabetic

retinopathy through a collaborative project with 

the Joslin Diabetes Center using the Joslin Vision

Network (JVN). JVN is a remote site diabetes

retinopathy screening system that uses low-level 

illumination and does not require pupil dilation.

The acquired retinal image is sent electronically to 

a reading center and the analysis sent back to the

remote site. IHS has established demonstration sites

at the IHS Phoenix Indian Medical Center (PIMC),

which serves as the central reading station, and the

Tohono O’odham (formerly Papago) Reservation at

Sells Public Health Service Indian Hospital. Staff

have been hired to implement the process and active

screening is taking place at both sites. The addition

of remote screening station sites at five additional

locations throughout the country is currently underway. Acquired retinal images from these remote 

sites will be electronically sent to the central reading 

station at PIMC. Primary challenges to future site

development in remote locations beyond these

demonstration sites include availability of communication lines and staffing.

NIDDK/IHS/TLDC/AIHEC collaboration to Recruit

AI/AN Students into Biomedical Science Research

and Diabetes Careers. In FY 2001, at the request of

tribal leaders serving on the Tribal Leaders Diabetes

Committee (TLDC), IHS and the National Institute of

Diabetes and Digestive and Kidney Diseases (NIDDK)

collaborated on a project to encourage young AI/AN

students to consider careers in biomedical research

and diabetes. This project also involves the American

Indian Higher Education Consortium (AIHEC), which

represents the 34 tribal colleges around the country,

and will target students in elementary, middle, and

high schools. Resources have been identified, a planning committee formed, and NIDDK plans to release

an RFA in FY 2002.

CDC/IHS Collaboration on Redesign of the National

Diabetes Prevention Center. The IHS National

Diabetes Program worked closely with the Centers

for Disease Control (CDC) Division of Diabetes

Translation (DDT) in FY 2001 to redefine and reestablish the National Diabetes Prevention Center

(NDPC) in Gallup, New Mexico, consistent with

NDPC’s original mission to provide diabetes outreach, information, and technical assistance to tribes

throughout the United States. In addition, the CDC

DDT provides diabetes educational and epidemiologic support to the IHS National Diabetes Program

with two full time positions and close collaboration

on projects of mutual concern.

Collaboration and Partnership With Other Federal

Agencies and Organizations. The IHS NDP Director

serves as a member of the newly formed Translation

Committee of the Diabetes Prevention Program, an

NIH-sponsored study showing that type 2 diabetes

can be prevented. The IHS NDP Director also serves

as a member of the Steering Committee of the

National Diabetes Education Committee, a joint

effort of the National Institutes of Health and CDC 

to promote national awareness about diabetes.

IHS NDP supports the American Diabetes Association's

outreach initiative program for AI/AN communities:

Strong in Body and Spirit. Provides expert guidance

related to diabetes program development and modification based on participant evaluation.

IHS NDP participates in the AI subcommittee of the

National Diabetes Education Program. IHS NDP provides regular representation to the committee and

helps with distribution of program materials. IHS

NDP partners with the National Indian Council on

Aging on a diabetes monograph series, newsletters

for tribal leaders, and development of an electronic

automated diabetes audit.
DMICC ANNUAL REPORT 13 FY 2001

A partnership has been established with the

American Indian Higher Education Consortium

(AIHEC) Board to help build tribal college and 

university capacity and infrastructure for diabetes

training and program activities in AI/AN 

communities.

Future Directions

IHS NDP plans to hold a national diabetes conference

in collaboration with the TLDC in Denver, Colorado,

in December 2002. The conference will feature successful grant programs and results of the Diabetes

Prevention Program study. IHS NDP will hold regional meetings with diabetes programs around the

country to discuss Best Practices and successful

models for implementation of diabetes prevention

and treatment in AI/AN communities.

IHS is planning for more training (for health professionals, tribal leadership, administrators, paraprofessionals, and patients) and increased awareness

regarding new diabetes prevention findings through

media, booklets, internet, and other avenues of communication.

National Center for Health Statistics (NCHS), CDC

NCHS’s mission as it relates to diabetes is to monitor

and provide national diabetes statistics in the form

of summary health measures and individual level

data for research. This information originates from

vital records, interview and examination surveys,

medical records, and patient encounters (such as

ambulatory care visits).

Highlights of FY 2000–2001 Activities

The National Health and Nutrition Examination

Survey (NHANES) continued to collect information 

on the prevalence of diagnosed and undiagnosed 

diabetes and assessment of the following measures

among people with diabetes (HbA1c, cholesterol,

blood pressure, visual acuity, lower extremity neuropathy and vascular insufficiency, renal function,

oral health, anthropometry, diet, and functional 

status).

In November 2000, NCHS published the baseline

tracking measures for the 2010 Health People national

health objectives. This included 17 diabetes objectives, which are the key diabetes health goals for 

the U.S. (http://www.cdc.gov/nchs/hphome.htm)

The NCHS Research Data Center now contains a 

followup data file, which was created by matching

participants from NHANES II and the Centers for

Medicare and Medicaid Services (CMS) (formerly

HCFA) end-stage renal disease (ESRD) program.

People with diabetes accounted for much of the

ESRD. (http://www.cdc.gov/nchs/r&d/rdc.htm) 

NCHS published numerous reports that included diabetes health statistics including trends in avoidable

hospitalizations for DKA (diabetic ketoacidosis) or

coma and urbanization patterns for the diabetes 

risk factors of obesity and sedentary leisure time

lifestyle.

Future Plans and Ongoing Initiatives

Release of the 1999–2000 NHANES data (see above) 

is scheduled for early 2002.

NHANES will be releasing fact sheets on the risk 

of chronic renal disease among people with diabetes,

which is based on the matched NHANES–CMS 

data file.
DMICC ANNUAL REPORT 14 FY 2001

Plans by the National Health Interview Survey (NHIS)

to periodically collect diabetes-related questions on

preventive measures related to diabetes including

diabetes education and frequency of vision, foot, or

HbA1c evaluations will be suspended until additional

funds are obtained by NCHS. 1999 was the last time

this NHIS information was obtained. In addition, no

plans exist to repeat the 1989 diabetes supplemental

survey in NHIS.

National Center for Research Resources (NCRR)

The National Center for Research Resources (NCRR)

develops and supports research technologies and

shared resources that are critically important to the

research efforts directed at maintaining and improving the health of our Nation’s citizens. To facilitate

health-related research, NCRR supports the development and use of sophisticated instrumentation and

technologies, animal models of human disease, and

clinical research environments. NCRR programs also

provide support for the career development of clinical and veterinary biomedical investigators. The current NCRR diabetes research portfolio includes

approximately 680 basic and clinical research subprojects. Selected highlights of NCRR-supported

research activities and future plans that relate to

diabetes are presented below.

Current Activities

NCRR established a network of 10 Islet Cell Resource

(ICR) centers to isolate, purify, and characterize

human pancreatic islets for subsequent transplantation into patients with type 1 diabetes.

Scientists are using electron microscopy to image 

the Golgi apparatus, a cellular component that is

essential for insulin secretion in beta cells, to study

its fine structure and function, and to gain a fundamental understanding of insulin secretion.

New nuclear magnetic resonance methods are being

developed in humans and mice to analyze and understand in vivo metabolic changes that occur in type 2

diabetics. A recent study in humans showed that

three separate pathways of glucose production in 

the liver could be monitored in a single experiment.

At the University of California Davis Regional Primate

Research Center (RPRC), xenografts of islet cells

from pigs to diabetic macaques were successful in

50 percent of the animals and showed functionality

for at least 3 months.

Researchers at the University of Washington RPRC

have been investigating pancreatic islet cell allograft

survival in macques and baboons. They found that

transplanting islets without immuno-suppression

followed by a second graft with immuno-suppression

facilitates allo-tolerance of the second graft.

Porcine models are being used to investigate the 

significance of coronary artery disease in type 2 

diabetics.

Advances at General Clinical Research Centers

(GCRCs) have been made in understanding the relationship between insulin peptides and type 1 diabetes pathogenesis. Approximately 75 percent of the

subjects in the Diabetes Prevention Trial–1 study are

cared for through GCRCs. Many of the participating

Centers use their core laboratories to measure plasma insulin levels and use their dieticians to analyze

dietary histories.
DMICC ANNUAL REPORT 15 FY 2001

Several GCRC investigators are studying the genetic

polymorphisms that predispose patients to type 2

diabetes while others are exploring the complications

that the disease causes in the vascular bed and 

blood clotting mechanism.

Diabetes-related research is being conducted at 

five NCRR-supported Research Centers at Minority

Institutions (RCMIs): University of Hawaii at Manoa,

Howard University, University of Puerto Rico Medical

Sciences Campus, Charles R. Drew University, and

the University of Texas El Paso.

The Charles R. Drew RCMI has established the

Center of Urban Research and Education in Diabetes

and Metabolism (CUREDM), which is in its second

year of funding, and continues to attract established

research investigators and provide them with

resources they need to study diabetes and its complications in disproportionately affected indigenous

populations.

The Howard University RCMI is starting Project DiSH

(Diabetes, Stroke and Hypertension) at two at-risk

urban minority school systems, which will provide 

a school-based program to increase awareness of

medical and lifestyle factors responsible for diabetes.

The Shaping Health Behaviors Through Science

Enrichment project at Colorado State University

focuses on students in grades K–6, using science 

education enrichment as a model for behavioral

change to reduce type 2 diabetes by improving 

nutrition and reducing the rate of childhood and 

adolescent obesity.

Future Activities

NCRR will increase support for ICR centers that 

will procure whole human pancreases, isolate the

islets, optimize the quantity and quality of the islet

preparations, and distribute islets to investigators

conducting approved research.

Collaborations with other components of NIH and

private organizations will continue and expand for

studies that enroll diabetic and prediabetic patients

for research into the etiology and treatment of diabetes. This will in part be through continued support

of national cooperative diabetes programs such as

DPP, DPT–1, EDIP, and EDIC as well as corporatesponsored drug trials.

Expand resources will be expanded to maintain and

supply genetically-engineered mouse models for 

diabetes mellitus research including hyperglycemia,

hyperinsulinemia, and insulin resistance.

NCRR plans to link the newly established diabetes

mutant mouse resource at the Jackson Laboratory

with the existing NCRR-funded Mutant Mouse

Regional Resource Center. The Jackson Laboratory

will house models that are standard inbred and

hybrid mice as well as mice with spontaneous and

induced mutations serving as models for diabetes

and obesity. A coordinated database will form the

backbone of this diabetes mouse resource.

Efforts to develop a non-human primate model for

diabetes will continue. The advent of molecular tools

enables the search for naturally occurring diabetes

in non-human primates as well as the detection of

genes involved in diabetes.

The Charles R. Drew CUREDM will continue to develop its research infrastructure, including the provision of support for pilot projects. The Center will be

expanding to house a telemedicine remote site and

exercise physiology center, and has received approval

to create an Ophthalmology CUREDM satellite.
DMICC ANNUAL REPORT 16 FY 2001

National Center on Minority Health 

and Health Disparities (NCMHD)

The mission of the National Center on Minority

Health and Health Disparities is to lead, coordinate,

support, and assess the NIH effort to reduce and 

ultimately eliminate health disparities. In this effort

NCMHD will conduct and support basic, clinical,

social and behavioral research, promote research

infrastructure and training, foster emerging programs,

disseminate information, and reach out to minority

and other health disparity communities. The NCMHD

envisions an America in which all populations will

have an equal opportunity to line ling, healthy and

productive lives.

Building on the work of the former Office of Research

on Minority Health (ORMH) through its partnerships

with the NIH institutes and centers (ICs), the NCMHD

has made remarkable achievements since its establishment just over one year ago. NCMHD is particularly committed to continuing its partnerships with

the National Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK) and other NIH ICs, supporting diabetes research and training. While diabetes

affects all groups in the U.S. population, Native

Americans, Mexican Americans, Puerto Ricans and

African Americans suffer disproportionately compared

to the general population. Findings in a recent

National Eye Institute/NCMHD funded study indicated

that increased efforts are needed to improve diabetes

detection in Mexican Americans.

The Center is addressing disparities in health status

in racial and ethnic minorities with respect to 

diabetes through the support of research in three

broad areas: preventing or delaying the early onset 

of diabetes through diabetes education and lifestyle

changes, improving the management of and therapies

for diabetes, and the identification of biological and

genomic risk factors for diabetes. Addressing one of

the barriers to racial and ethnic minority individuals’

participation in clinical trials – lack of racial and

ethnic minority clinical investigators and researchers

—NCMHD is continuing to support research training

at minority health professional schools. Two such

programs include a clinical trials faculty development program and a research training alliance

through one of NIDDK’s Diabetes Research and

Training Centers.

National Eye Institute (NEI)

The National Eye Institute’s mission is to conduct

and support research, training, health information

dissemination, and other programs concerned with

blinding eye diseases, visual disorders, mechanisms

of visual function, preservation of sight, and the special health problems and requirements of the blind.

Diabetes is responsible for diabetic retinopathy, an

eye disease that is the leading cause of blindness in

people between the ages of 24 and 70 years. This 

disease is characterized by a progressive breakdown

of the normal retinal vascular system.
DMICC ANNUAL REPORT 17 FY 2001

Current Activities

NEI sponsorship of the workshop entitled “”Genetics

of Diabetic Retinopathy” on September 21–22, 2000,

in Bethesda, Maryland, resulted in publication of a

program announcement (PA–02–020), entitled

“Strategies to Identify the Genetic Basis of Diabetic

Retinopathy.” This PA seeks grant applications on

gene discovery; genetic epidemiology; methodological

studies of phenotypic assessment of retinopathy,

including possible surrogate markers; and the development and application of novel statistical methods

relevant to analyzing genetic data on diabetic

retinopathy. This PA is co-sponsored by the National

Institute of Diabetes and Digestive and Kidney

Diseases (NIDDK). In addition, NEI is participating

with other NIH institutes in a PA entitled “The Role

of Antioxidants in the Prevention of Diabetic

Complications.” The intent of this PA is to solicit

applications on the role of antioxidants in preventing, delaying, or ameliorating the micro- or

macrovascular complications of diabetes as well 

as the mechanism(s) by which antioxidants might

prevent diabetic vascular disease.

NEI has joined with other NIH institutes in several

RFAs (Requests for Applications). RFA–DK–02–016,

“Surrogate Endpoints for Diabetic Macular

Complications,” invites applications to develop biological endpoints that can be used to predict risk and

assess progression of microvascular complications of

diabetes. RFA–DK–02–023, “Innovative Partnerships

in Type 1 Diabetes Research,” is intended to support

collaborations between investigators already engaged

in diabetes research and researchers from other

areas with expertise relevant to type 1 diabetes

research. RFA–DK–02–022, “Bench to Bedside

Research on Type 1 Diabetes and Its Complications,”

seeks applications involving partnerships between

clinical and basic biomedical researchers with the

goal of translating advances of the molecular basis

of type 1 diabetes into new therapies.

NEI continues to participate with NIDDK, the

National Institute of Dental and Craniofacial

Research (NIDCR), the National Institute of Neurological Disorders and Stroke (NINDS), and the

National Heart, Lung and Blood Institute (NHLBI) 

in a program announcement (PA–99–159) on “The

Role of Growth Factors in the Development of

Diabetic Complications.” This PA encourages grant

applications on the role of growth factors in the 

etiology and pathogenesis of the micro- and

macrovascular complications of diabetes.

NEI is helping to co-sponsor ACCORD (Action to

Control Cardiovascular Disease Risk in Diabetes),

a large multicenter trial supported by NHLBI and

NIDDK to assess treatments to reduce risk of cardiovascular disease in type 2 diabetes. For this transNIH effort, NEI is sponsoring an eye examination

component in order to collect epidemiological data.

Through its National Eye Health Education Program

(NEHEP), NEI coordinated the National Diabetes

Month (NDM) Eye Health Initiative in November

2000. This initiative was designed to increase awareness of diabetic eye disease and the importance of

dilated eye exams for the 10 million people diagnosed with diabetes. The NEHEP Partnership, which

represents more than 60 leading public and private

organizations, sponsored the awareness month.

Community resource guides and educational materials were distributed to health professionals and community organizations nationwide for use in conducting local programs and events. In addition, diabetic

eye disease information was disseminated to both

English and Spanish print and radio media and to

Spanish language television stations.
DMICC ANNUAL REPORT 18 FY 2001

Consistent with the recommendations of the congressionally established Diabetes Research Working

Group (DRWG), NEI is supporting an initiative on the

evaluation of new treatments for diabetic macular

edema, a major cause of visual loss in patients with

diabetes. An RFA (EY–01–001) entitled “Diabetic

Macular Edema Clinical Research Network” was

issued in June 2001 and calls for cooperative agreement applications to support core centers to plan,

implement, and conduct clinical trials on the treatment of diabetic macular edema. Clinical centers will

be added to the network during the first year of operation. The overall goal of this RFA is to develop an

infrastructure to accelerate the development and

conduct of clinical trials of the treatment of diabetic

macular edema. These include both medical and surgical approaches. A pilot study is being developed at

the NEI clinical center to pilot methods to evaluate

less intense photocoagulation, vitamin E supplementation, COX–2 inhibitors, and lipid lowering. The pilot

study is intended to set the stage for a major multicenter randomized clinical trial for the treatment of

diabetic macular edema.

Another initiative seeks to identify genetic associations in patients with microvascular complications of

diabetes. NEI is supplementing the FIND (Family

Investigation of Nephropathy and Diabetes) study

funded by NIDDK to investigate the genetics of individuals and special populations of patients with

renal disease. NEI is supporting detailed eye examinations for these patients and will search for genetic

associations with microvascular disease.

Future Activities

NEI will continue to incorporate the scientific 

priorities outlined in the Report of the

Congressionally Established Diabetes Research

Working Group in making funding decisions.

NEHEP will continue to develop and implement 

outreach activities for people with diabetes.

NEI will continue to encourage experienced investigators from outside vision research to apply their

expertise to develop novel strategies for increasing

knowledge about the pathophysiology and treatment

of diabetic retinopathy.

National Heart, Lung and Blood Institute

(NHLBI)

NHLBI has continued to pursue a comprehensive

research program to understand the pathogenesis,

improve treatment, and develop effective prevention

strategies to address the cardiovascular complications of diabetes, the major cause of death in

patients with diabetes. Despite reductions in cardiovascular disease (CVD) mortality in the general population, patients with diabetes continue to have 2–4

times the CVD rates of non diabetics of the same age

and gender. In addition, recent studies indicate that

current treatments to prevent these complications

may be somewhat less effective among those with

diabetes than in the non-diabetic population.
DMICC ANNUAL REPORT 19 FY 2001

Current Activities

During the past year, NHLBI has initiated recruitment for two major clinical trials that will evaluate

several therapeutic approaches designed to reduce

cardiovascular complications of diabetes. The Action

to Control Cardiovascular Disease Risk in Diabetes

(ACCORD) trial is conducting a 1,000 patient vanguard phase. If the vanguard is successful, ACCORD

will study 10,000 patients over the next 5 years to

evaluate the benefits of intensified control of hyperglycemia over more conventional glucose control and

also test the benefits of aggressive blood pressure

control and intensified control of the dyslipidemia

associated with diabetes upon CVD rates.

The Bypass Angioplasty Revascularization

Investigations II Diabetes (BARI 2D) trial will study

2,800 patients and evaluate whether elective coronary artery revascularization plus optimal medical

management of cardiovascular risk factors and

symptoms is superior to optimal medical management alone. It will also evaluate the important issue

of whether reducing insulin resistance provides protection against cardiovascular complications by testing whether insulin- sensitizing drugs are superior

to injected insulin or to oral drug regimens that stimulate insulin secretion at levels of glycemic control

that are attainable with current conventional treatments. The National Institute of Diabetes and

Digestive and Kidney Diseases (NIDDK) is providing

partial support for both of these trials.

NHLBI is also helping to fund the NIDDK-sponsored

Action for Health in Diabetes (Look AHEAD) trial,

which will evaluate the effect of obesity treatment 

on cardiovascular complications in type 2 diabetic

patients.

While these trials should lead to clinical approaches

that reduce cardiovascular complications of both

type 1 and type 2 diabetes, additional more basic

research is necessary to identify other ways in which

this major complication of diabetes can be retarded

or prevented. In view of the complexity of the available treatments and the burden they place on

patients with diabetes, it is particularly important to

develop new therapies that can reduce the adverse

effects of diabetes on the heart and large vessels

without requiring intensive efforts at glucose control. NHLBI has expanded basic research related to

macrovascular complications of diabetes including

large program project grants originally cosponsored

with the Juvenile Diabetes Foundation.

NHLBI has also participated, in collaboration with

NIDDK, in the program of small, innovative grants

aimed at improved understanding of diabetic

macrovascular complications. These have involved

studies of the effects of diabetes on vascular smooth

muscle cells, its effect on circulating growth factors,

and the effect of salt restriction on insulin sensitivity. Last year, a new initiative was funded to understand the etiology of diabetes-associated cardiomyopathy, an abnormality that may contribute to the

high rates of congestive heart failure in diabetic

patients.

A major recommendation of the 1997 Diabetes

Research Working Group report was to develop

improved animal models of diabetic complications,

a crucial limiting factor in expanding studies of how

diabetes produces chronic micro- and macrovascular

changes. During the past year, new Requests for

Applications (RFAs) were released to stimulate development of these models. While collaborating on the

NIDDK-led mouse model initiative, NHLBI sponsored

an initiative to develop larger animal models for

studies of vascular complications of diabetes.
DMICC ANNUAL REPORT 20 FY 2001

Finally, it is important to recognize that many of the

other research efforts supported by NHLBI may help

to reduce or improve treatment for cardiovascular

diseases occurring in patients with either type 1 or

type 2 diabetes. This is because the effect of diabetes

on macrovascular disease is, at least in part, to accelerate progression of the underlying atherosclerosis

that is also common in non-diabetic individuals in

middle and older ages. Thus, studies on treatment of

congestive heart failure, treatment of arrhythmias,

including public access to defibrillation, stent

implantation, regeneration of cardiac muscle, and

other treatments may have major benefits for

patients with diabetes.

NHLBI support for studies of diabetes-related

macrovascular disease has continued to increase.

Funding for this work expanded further as the major

clinical trials began actively recruiting participants

in FY 2001. Taken together, these clinical and basic

studies should provide better guidance for physicians to reduce cardiovascular complications of 

diabetes in the near future and provide easier to 

use, more effective therapies to achieve this goal in

later years.

National Human Genome Research Institute

(NHGRI)

The National Human Genome Research Institute 

supports two ongoing diabetes projects being conducted by investigators in the Division of Intramural

Research and their collaborators. Both studies aim 

to identify genetic variations that lead to increased

susceptibility to type 2 diabetes mellitus.

Current Activities

Africa America Diabetes Mellitus Study (AADM).

During the past several years, the National Center for

Minority Health and Health Disparities, formerly the

Office of Research on Minority Health, and NHGRI

have supported an innovative research collaboration

between investigators from Howard University and

scientists in NHGRI’s Division of Intramural

Research. The collaboration involves support for a

project aimed at finding the genetic contribution to

type 2 diabetes in African Americans. To achieve this

and other research goals, NHGRI assisted Howard

University in establishing a Center for collaborative

research on genomic analyses of diseases that disproportionately affect African Americans. The

National Human Genome Center at Howard

University was dedicated on May 1, 2001. Initial

efforts to define the scientific focus and objectives of

the Center’s diabetes research efforts were addressed

through peer-reviewed contracts with Howard

University as the Coordinating Center for the Africa

America Diabetes Mellitus Study.

Because of the high frequency of environmental risk

factors for diabetes in the African-American population, it is potentially more powerful to study genetic

risk factors in West Africans, since they are thought

by many anthropologists to be the founding population of modern African Americans and have fewer

dietary and nutritional confounding variables. To

establish recruitment sites for the study, five sites

were selected through a peer review process from a

total of 24 applications, three of them from diabetologists in Nigeria and two of them from diabetologists in Ghana. Because of logistical challenges

involved in doing a study of this type in West Africa,

the study was planned in stages to allow assessment

of the sites’ ability to recruit appropriate patients

and collect blood, urine, and other clinical data and

successfully send the samples and data to the

Coordinating Center at Howard University. The 1-year

pilot project fully met its goal of recruiting 15 affected sibling pairs/site. Based on this experience, a fullscale study was implemented in September 1998 to

recruit 400 affected sibling pairs and 200 spouse
DMICC ANNUAL REPORT 21 FY 2001

controls from West Africa by the end of the study

period; this goal has also been fully met. Genetic

analysis of the blood samples was performed this

year at the Center for Inherited Disease Research

(CIDR); a centralized facility established by NIH to

provide genetic services for investigators seeking to

identify genes that contribute to human disease. The

services for the AADM study were awarded through a

competitive application process. The data generated

at CIDR are currently under analysis at Howard

University. The study has not only started to yield

high quality data, but has assisted in the recruitment

of several top-flight scientists to the National Human

Genome Center at Howard University.

Finnish US Investigation Of NIDDM Genetics

(FUSION). NHGRI assisted in the development of a

consortium of groups who have agreed to pool their

linkage data on type 2 diabetes in order to study the

genetic factors involved in this disease. The consortium currently has support from the National

Institute of Diabetes and Digestive and Kidney

Diseases and includes all of the major groups in the

United States with large family collections as well as

a few European groups. The consortium already has

completed an analysis of chromosome 20, and is

moving on to look at the rest of the genome.

NHGRI’s intramural research program includes a

major project, known as the Finland-United States

Investigation Of Non-Insulin Dependent Diabetes

Mellitus (abbreviated FUSION), which aims to identify susceptibility genes for type 2 diabetes and for the

related intermediate quantitative traits in a Finnish

population. The data from the FUSION project 

represents a major component of the type 2 diabetes

consortium's effort. A genome search for genes conferring susceptibility to diabetes, or intermediate

traits such as insulin resistance, was completed on

DNA from approximately 3,280 individuals using

more than 400 genetic markers. The project already

has identified regions on chromosomes 20 and 11

that seem to harbor susceptibility genes. Further statistical evaluations of the data, including quantitative trait linkage and association analyses, have identified additional chromosomal locations that may

contain susceptibility genes. These and several other

potential gene locations are being followed up by

candidate gene evaluation and linkage disequilibrium

analysis in this unique population.

Future Activities

Technology Development for Natural Genetic

Variation. NHGRI started a program to establish 

new academic Centers for advanced genome research.

These Centers of Excellence in Genomic Science

(CEGS) will support multi-investigator,

interdisciplinary teams to develop innovative genomic approaches to address biological problems. One 

of the CEGS aims to develop and apply tools for

studying natural genetic variation directed toward

developing an improved understanding of the 

molecular basis of genetic susceptibilities to type 1

diabetes, progressive supranuclear palsy, and 

neutropenia.

Cultural and Ethical Issues Associated with Genetic

Family Studies. The Institute’s Ethical, Legal and

Social Implications (ELSI) Program was designed to

provide a novel approach to scientific research by

identifying, analyzing and addressing the ethical,

legal, and social implications of human genetics

research at the same time that the basic scientific

issues are being studied. This specific project aims to

examine cultural and ethical issues associated with

participation in genetic family studies by patients

with a family history of type 2 diabetes mellitus in

order to enhance the ascertainment process and

establish strategies for genetic counseling of patients

and relatives with a family history of type 2 diabetes

and diabetic neuropathy.
DMICC ANNUAL REPORT 22 FY 2001

National Institute of Allergy and Infectious

Diseases (NIAID)

Fiscal Year 2001 (FY2001) information was 

not available.

National Institute of Arthritis and

Musculoskeletal and Skin Diseases (NIAMS)

Fiscal Year 2001 (FY2001) information was 

not available.

National Institute of Biomedical Imaging and

Bioengineering (NIBIB)

The mission of the National Institute of Biomedical

Imaging and Bioengineering (NIBIB or EB) is to

improve health by promoting fundamental discoveries,

design and development, and translation and assessment of technological capabilities in biomedical

imaging and bioengineering, enabled by relevant areas

of physics, chemistry, mathematics, materials science,

information science, and the computer sciences.

Current Activities

The Institute plans, conducts, fosters, and supports

an integrated and coordinated program of research

and research training that can be applied to a broad

spectrum of biological processes, disorders and 

diseases, and organ systems.

The Institute coordinates with the biomedical imaging and bioengineering programs of other agencies

and NIH Institutes to support imaging and engineering research with potential medical applications and

facilitates the transfer of such technologies to medical applications.

Within this mission, NIBIB supports hypothesis-,

design-, technology- or problem-driven research

relating to the discovery, design, development, translation, and physical assessment of new knowledge 

in biomedical imaging and bioengineering. The

knowledge gained and the technologies developed in

this endeavor will be transferred to other Institutes

for the refinement and optimization that is uniquely

organ- or disease-specific.

Future Activities

Diabetes research supported by NIBIB will encompass

investigation of future methods to image and cope

with this disease. The potential applicability of these

research results will enable diabetes researchers to

improve the well being of individuals with diabetes.

National Institute of Child Health and 

Human Development (NICHD)

The mission of the National Institute of Child Health

and Human Development is to promote the development of healthy children. Understanding genetic and

environmental factors that contribute to the development of diabetes is consistent with this mission,

given the prevalence of both type 1 and type 2 diabetes in children and the serious complications of

diabetes later in life. NICHD focuses its efforts on the

earliest pathogenesis of type 1 diabetes and on optimizing insulin therapy in children with type 1 diabetes. In addition, NICHD has targeted research on

the origins of type 2 diabetes in adolescents and on

improving the outcome of pregnancy in women 

with gestational diabetes mellitus.
DMICC ANNUAL REPORT 23 FY 2001

Current Activities

In efforts to prevent type 1 diabetes, NICHD has 

pioneered methods in stratifying levels of risk for

type 1 (juvenile) diabetes mellitus according to genetic

and immunologic markers. This work forms the basis

of the Diabetes Prevention Trial for Type 1 Diabetes,

a major collaborative, trans-NIH study aimed at 

preventing or delaying the onset of type 1 diabetes.

NICHD also continues its collaboration with the

Juvenile Diabetes Research Foundation International

(JDRF) to co-fund a large prospective study of infants

who have relatives with type 1 diabetes, to ascertain

the earliest changes in gene expression in those 

children who become diabetic.

Recently NICHD completed a clinical research study

entitled “Tolerability and Pharmacokinetics of Inhaled

Insulin in Children 6–11 Years of Age with Type 1

Diabetes.” Up to 36 units of insulin can be delivered

through the airway system of the lungs. This study

showed that inhaled insulin is as efficacious as

insulin injected subcutaneously and represents a new

departure in the treatment of diabetes, overcoming

children’s fear of injections and difficulty in complying with intensive insulin therapy.

NICHD is currently supporting a 16-site, prospective,

international study of hyperglycemia and adverse

pregnancy outcomes. This study of gestational diabetes

mellitus will enroll 25,000 women early in their 

pregnancy and will follow them through their gestation, delivery, and postpartum period. Their infants

will be studied as well. The National Institute of

Diabetes and Digestive and Kidney Diseases (NIDDK)

is co-funding this large study. In 2001, NICHD funded

eight new grant applications in response to Requests

for Applications (RFAs) in the areas of fetal origins of

adult disease and prevention of type 2 diabetes in

adolescents. Both of these initiatives focus on early

pathogenesis of insulin resistance and glucose intolerance prior to the onset of clinical diabetes.

Congressional Report 106–293 encourages NICHD 

to work with the National Institute of Allergy and

Infectious Diseases (NIAID) and NIDDK on efforts to

develop a vaccine to prevent juvenile or type 1 

diabetes. In response to this Report, NICHD joined

NIDDK in co-funding TrialNet, a Network of 14 

centers designed to perform clinical trials of new

immunomodulatory agents to treat, delay, or prevent

the onset of type 1 diabetes. NICHD also joined

NIDDK and NIAID in co funding the Cooperative Study

Group for Autoimmune Disease Prevention, a network

of investigators who are developing new methods to

induce immune tolerance to self-antigens of the beta

cells of the pancreas. Ultimately, this collaborative

research promises to mitigate or reverse the autoimmune process that leads to type 1 diabetes.

NICHD also initiated a Cooperative Multicenter

Research Network to test glucose sensors in children

with type 1 diabetes. This effort is designed to reduce

the incidence of hypoglycemic attacks in diabetic

children on intensive insulin therapy. This multicenter trial of glucose sensors in children will utilize

funds appropriated by Congress for research in 

type 1 diabetes for the first 3 years and will then be

co-funded by NICHD and NIDDK.

NICHD’s Intramural Research Program is following

children in a 15-year study designed to understand

the earliest pathogenesis of insulin resistance and

glucose intolerance in obese children and in nonobese children of obese parents. These investigators

are also studying the effects of metformin and 

orlistat in obese insulin-resistant children.
DMICC ANNUAL REPORT 24 FY 2001

Future Activities

NICHD’s Intramural program plans to initiate a casecontrol study of new-onset type 1 diabetes to elucidate the genetic and environmental factors that 

interact to initiate the autoimmune attack on the beta

cells of the pancreas. The Pediatric Pharmacology

Research Unit Network plans to augment its Phase 1

and Phase 2 studies of new molecular entities

designed to ameliorate glucose intolerance in children

and adolescents.

The incidence of type 1 diabetes has increased steadily over the past 30 years. It is presumed that environmental factors account for this striking increase in

incidence. Epidemiologic studies and animal models

implicate cow milk antigens in infant formula as an

environmental agent that may trigger the autoimmune attack. Screening will begin next year to find

2,800 infants at high genetic risk of type 1 diabetes,

based on HLA genotype. The infants will be randomized to standard infant formula or to Nutramigen” a

casein hydrolysate. The investigators will follow the

development of autoantibodies in these children

through 2005. Meade-Johnson will provide the standard formula and the Nutramigen”. The study will be

funded by NICHD, NIDDK, the Juvenile Diabetes

Research Foundation International, The Canadian

Institutes of Health Research, the European

Foundation for the Study of Diabetes, and the

Netherlands Diabetes Foundation.

National Institute of Dental and Craniofacial

Research (NIDCR)

The mission of NIDCR is to support research on the

causes, prevention, diagnosis, and treatment of oral

and craniofacial diseases and conditions, including

oral complications associated with diabetes. These

complications include greater prevalence and severity of periodontal diseases, increased susceptibility to

oral mucosal infections, impaired wound healing,

salivary gland dysfunction, and neuropathies resulting in loss or alteration of taste, smell, and mucosal

sensory perception. NIDCR also supports research on

the effects of oral diseases and conditions on metabolic control of blood glucose.

Current Activities 

NIDCR and the American Academy of Periodontology

co-sponsored a conference “The Periodontal –

Systemic Diseases Connection,” which addressed

relationships between oral health and diabetes

(Bethesda, Maryland; April 18–20, 2001). This meeting

identified research gaps including a need for clinical

intervention studies to better determine the connection between periodontitis and diabetes. Proceedings

of the meeting will be published in the Annals of

Periodontology in 2002.

NIDCR support for diabetes research in FY 2001

included support for six new Exploratory Grants

(R21s) to develop new approaches for the study of 

the microbiology and immunology of type 1 diabetes.
DMICC ANNUAL REPORT 25 FY 2001

Ongoing NIDCR-supported basic research included

studies on:

• The role of non-enzymatic glycation of extracellular

proteins in periodontal diseases.

• Impaired macrophage/monocyte function in

patients with diabetes.

• Mechanisms underlying gingival connective 

tissue destruction in patients with diabetes.

• Regulation of B-cell autoimmunity by 

Interleukin-10.

• Characterization of diagnostic pancreatic 

autoantigens in serum and saliva of type 1 

diabetes patients 

Translational and clinical research/clinical trials

supported included studies on:

• Salivary gland dysfunction in animals and 

humans with diabetes .

• Diabetes as a risk factor for periodontitis.

• A randomized clinical trial to evaluate the effect 

of treating periodontal infection on improving

glycemic control in type 2 diabetes patients.

In addition, epidemiological studies were initiated 

on oral complications and oral health status in type I

diabetics and on the associations between periodontitis, diabetes, and heart disease. A training and

career development program to develop researchers

with skills needed to study relationships between

oral and systemic diseases, including diabetes, also

received FY 2001 support.

Future Activities

NIDCR continues to participate in two active program announcements (PAs), “The Role of Growth

Factors in the Development of Diabetes Complications”

and “Enhancing Adherence to Diabetes SelfManagement Behaviors.” The National Institute of

Diabetes and Digestive and Kidney Diseases and

NINR, respectively, were the lead Institutes on these

PAs issued collaboratively with several other

Institutes. No additional initiatives are planned.

National Institute of Diabetes and Digestive 

and Kidney Diseases (NIDDK)

The National Institute of Diabetes and Digestive and

Kidney Diseases is the lead agency of the Federal

Government for research efforts to combat diabetes

and its complications. The Division of Diabetes,

Endocrinology, and Metabolic Diseases has responsibility for extramural programs related to diabetes

research and research training. The Division of

Intramural Research, the Division of Digestive

Diseases and Nutrition, and the Division of Kidney,

Urologic and Hematologic Diseases support additional diabetes-related activities. In addition, NIDDK is

responsible for overseeing the deployment of special

funds to support research on the prevention and cure

of type 1 diabetes provided through the Balanced

Budget Act of 1997 (P.L. 105–33) and its subsequent

extension in Section 931 of the Benefits Improvement

and Protection Act of 2000 (P.L. 106–554).

Current Activities

NIDDK supports a vigorous program of both basic

and clinical research to further understanding of the

development, treatment, prevention, and cure of diabetes and its complications. To maximize research on

diabetes, the Institute has fostered collaborations

among the many Institutes and Centers of the
DMICC ANNUAL REPORT 26 FY 2001

National Institutes of Health (NIH), as well as with

the Centers for Disease Control and Prevention 

(CDC), the Juvenile Diabetes Research Foundation

International (JDRF), and the American Diabetes

Association (ADA). Some examples of ongoing 

activities and new initiatives for FY 2001 follow.

Type 1 Diabetes. Type 1 diabetes most often occurs 

in children, but can appear at any age. Formerly

known as insulin-dependent or juvenile-onset diabetes, it accounts for 5 to 10 percent of all diabetes

in the U.S. It occurs equally among males and

females, but is more common in Caucasians than in

non-Caucasians. Type 1 diabetes develops when the

immune system turns against itself in a disease

process termed “autoimmunity.” The immune system

destroys clusters of cells in the pancreas called

islets, which contain the body’s insulin-producing

beta cells. Once these cells are destroyed, type 1 diabetes patients require either lifelong insulin injections, often multiple times throughout the day, or

infusion of insulin via a pump to control their blood

glucose levels. Insulin therapy, however, is not a cure,

nor can it always prevent the long-term complications of the disease.

NIDDK is spearheading a major clinical trial, the

Diabetes Prevention Trial for Type 1 Diabetes (DPT–1),

to prevent the development of type 1 diabetes in people at risk. DPT–1 is now testing whether oral insulin

can prevent type 1 diabetes in people with a moderate risk of developing type 1 diabetes within 5 years.

The same study group recently completed a separate

trial that found that low-dose insulin injections do

not prevent type 1 diabetes in people with impaired

insulin secretion who have a high risk of developing

the disease within 5 years. The oral insulin trial is

testing a different scientific approach to preventing

type 1 diabetes in individuals whose insulin production is not yet impaired. The National Institute of

Allergy and Infectious Diseases (NIAID), the National

Institute of Child Health and Human Development

(NICHD), the National Center for Research Resources

(NCRR), JDRF, ADA, and industry also support DPT–1.

A new NIDDK initiative that will facilitate additional

clinical research on type 1 diabetes is the Type 1

Diabetes TrialNet. Spearheaded by NIDDK, this effort

is co-sponsored by NIAID and NICHD. TrialNet will

include clinical centers, recruitment networks, and 

a coordinating center. It will provide the research

infrastructure needed for future design and execution of pilot studies and expanded clinical research.

TrialNet will permit more rapid clinical testing of

novel approaches to treatment and prevention of 

type 1 diabetes. TrialNet will also enable efficient

performance of intervention studies to preserve 

pancreatic beta cell function in new-onset cases of

type 1 diabetes, and ultimately to prevent onset of

the disease.

The Diabetes Control and Complications Trial (DCCT)

established the importance of intensive diabetes 

control in type 1 diabetes to dramatically reduce the

devastating complications that can result. However,

with current treatment modalities, tight control

remains an unattainable goal for many people with

diabetes. Episodes of severe hypoglycemia are the

major obstacle to the achievement of euglycemia 

and the prevention of long-term complications.

Hypoglycemia is frightening to the patients and their

families. Diminished brain function during a hypoglycemic episode poses potential physical danger to

the patient. In addition, recurrent hypoglycemia may

impose long-lasting damaging effects on the brain,

resulting in impairment of memory or other cognitive

functions. This is especially concerning in the early

childhood years when the nervous system is still

developing. Over time, individuals may not be aware

of the significant drop in blood glucose levels—a

condition known as hypoglycemia unawareness. To

highlight the problem of hypoglycemia in individuals

with diabetes, JDRF, ADA, NIDDK, the National

Institute of Neurological Disorders and Stroke

(NINDS), NICHD, and the National Aeronautics and

Space Administration (NASA), co-sponsored a workshop entitled “Hypoglycemia and the Brain.” An initiative developed from recommendations of the workshop will define the mechanisms underlying the loss

of hypoglycemia awareness in patients with diabetes

and develop novel approaches to prevent or reverse
DMICC ANNUAL REPORT 27 FY 2001

hypoglycemia unawareness. Related research will

define the scope and nature of hypoglycemia in individuals with diabetes and develop and test strategies

to prevent the development of hypoglycemia or to

ameliorate its effects.

In related research, NIDDK is co-sponsoring the 

creation of a Type 1 Diabetes in Children Research

Consortium, led by NICHD. The Consortium will

develop and implement a protocol using continuous

glucose monitoring devices in children with type 1

diabetes to evaluate the utility of the devices and to

determine if continuous monitors are useful in

improving glycemic control and preventing hypoglycemia in children with the disease. This study

should complement knowledge gained about the

risks and benefits of intensive therapy in adolescents

and adults during and after the DCCT.

The Beta Cell. Gaining knowledge about the beta 

cells of the pancreatic islets is important to both

type 1 and type 2 diabetes because they are the key

to insulin production and resulting glucose control.

Two major conferences addressed this important

research area in diabetes. NIDDK, along with ADA

and JDRF, sponsored a conference entitled

“Pancreatic Development, Proliferation, and Stem

Cells.” This 2-day workshop brought together investigators from multiple disciplines doing state-of-theart research in developmental biology of the pancreas, islet cell biology, and stem cells. A second conference, “Beta Cell Biology in the 21st Century:

Engineering a Pathway to Greater Understanding,”

was sponsored by NIDDK, JDRF, ADA, and Lilly

Research Laboratories. This workshop showcased

recent progress in beta cell biology and exciting new

results in other systems that will impact future work

in the beta cell. It also provided a forum to explore

new research directions provided by emerging

genomic and proteomic information.

One of the extraordinary research opportunities 

recommended by the congressionally established

Diabetes Research Working Group was to better

define signaling in the beta cell and to use this

increased knowledge of beta cell biology to develop

novel treatments for diabetes. To this end, NIDDK 

has initiated the “Comprehensive Beta Cell Project,”

which includes the “Functional Genomics of the

Developing Endocrine Pancreas” project and the “Beta

Cell Biology Consortium.” Together these projects are

designed to enumerate all the protein coding regions

uniquely expressed in the developing and adult beta

cells from human and mouse, to clone the associated

mRNAs, and to gain a better understanding of beta

cell development and differentiation in hopes of

obtaining an unlimited supply of new beta cells or

islets for use in long-term treatment of 

type 1 diabetes.

NIDDK has also initiated a functional genomics program, the Diabetes Genome Anatomy Project (DGAP),

which has initially focused on the endocrine pancreas and has as a major goal development of tools

that are targeted to restoration of pancreatic beta

cell function. This program involves a consortium 

of investigators at Washington University, the

University of Pennsylvania, and Harvard University

with expertise in pancreatic development, functional

genomics and bioinformatics. This program will catalog all genes expressed in the developing mouse pancreas and make clones available through the IMAGE

consortium. The Center for Bioinformatics at the

University of Pennsylvania will soon release a Webbased database that will contain tools to aid

researchers in expression profiling, gene discovery,

and promoter analysis.

Microarrays developed by this consortium should

prove valuable for studies of islet cell development,

bioengineering of beta cells, and stem cell biology.
DMICC ANNUAL REPORT 28 FY 2001

Little is known about the natural history of beta cell

mass, turnover, and cell lifetime, or the course of

inflammation in diabetes. This is principally because

the pancreas is a highly heterogeneous organ that is

difficult to biopsy, and beta cell mass comprises only

1 to 2 percent of the organ. Imaging technology has

advanced rapidly in recent years, making it possible

to image small or deep structures that have until

now been impossible. It would be of great benefit to

the diabetes community to be able to image the cells

of the pancreatic islets. NIDDK has re-issued a solicitation to further stimulate the development of techniques or reagents leading to the ability to image or

otherwise non-invasively detect pancreatic islet beta

cells in vivo, and to measure their mass, function, or

evidence of inflammation, or to monitor engraftment

of transplanted pancreatic islets. It is anticipated

that research in this area will lead to eventual development of a clinical exam that can be used for monitoring disease progress and response to therapy in

diabetics and in people at risk for diabetes.

Islet Transplantation for Type 1 Diabetes. For

decades, researchers have been searching for ways 

to treat, prevent, and ultimately cure type 1 diabetes.

They have pursued means other than the external

administration of insulin to regulate blood glucose

levels and/or to restore insulin-producing capacity.

Successful transplantation of the whole pancreas is

the most common procedure to re-establish normal

blood glucose regulation; however, this procedure

entails major surgery and is usually done only in

conjunction with a kidney transplant in those individuals with end-stage renal disease. Moreover, it is

not a feasible therapy for young children with type 1

diabetes. Therefore, scientists have been concentrating on methods for replacing only the insulin-producing islets isolated from a donor pancreas.

In pursuing this area of research, NIDDK, in a collaborative effort with NIAID and JDRF, has supported

numerous centers to develop improved protocols for

islet transplantation in humans. In complementary

research, NIDDK, in conjunction with the Department

of the Navy, has established a Transplantation and

Autoimmunity Branch that will explore new

approaches to both kidney and islet transplantation

for diabetes. The Walter Reed Army Medical Center

and the University of Miami’s Diabetes Research

Institute are also collaborating on this research.

NIDDK and JDRF are also co-sponsoring the Immune

Tolerance Network (ITN), a collaboration involving

numerous research institutions spearheaded by

NIAID. The ITN will solicit, develop, implement, and

address clinical strategies, including biological

assays, for the purpose of inducing and maintaining

immune tolerance in patients receiving kidney and

islet transplants. The Transplantation and

Autoimmunity Branch of the NIDDK Division of

Intramural Research is one of 11 centers participating in ITN’s testing of the “Edmonton Protocol” in

performing transplant procedures in a larger number

of patients. This clinical research will further assess

the effectiveness of the technique and identify any

long-term risks associated with steroid-free immunosuppressive therapies. Researchers hope the study

will serve as a platform for testing new treatments in

which the permanent reversal of diabetes can be

achieved without the lifelong need for immunosuppressive drugs. In addition, NIDDK will support two

additional studies to determine if one pancreas can

provide sufficient islets for transplantation into one

patient. In support of all of these efforts, NCRR is

establishing several centers aimed at maximizing

islet harvesting processes.

One barrier to widespread islet transplantation is 

the limitation in the supply of islets from donor pancreata. Ex vivo gene transfer approaches may be 

one method to engineer beta cells or to alter islets 

to enhance viability that could have advantages for

transplantation. NIDDK and NIAID are soliciting

pilot and feasibility studies to explore gene transfer

techniques that could be applied to enhance islet

transplantation.
DMICC ANNUAL REPORT 29 FY 2001

Type 2 Diabetes. Type 2 diabetes is the most common

form of the disease. Once known as non-insulindependent or adult-onset diabetes, it affects about 

90 to 95 percent of people with diabetes. Two factors

play an important role in the growing public health

burden of type 2 diabetes—the changing demographics of America in terms of age, ethnicity, and race and

the increasing prevalence of obesity, a major risk 

factor for the disease. Diabetes is the sixth leading

cause of death in the U.S. and the third leading cause

of death in some minority groups. It places an especially heavy burden on growing segments of the U.S.

population—elderly and minority groups. NIDDK is

spearheading NIH-wide research efforts to combat

diabetes and obesity in order to stem the tide of this

devastating disease.

For those at risk for type 2 diabetes, results from a

major NIDDK clinical trial are providing important

knowledge about prevention strategies. The results of

the Diabetes Prevention Program (DPP) demonstrate

that individuals with IGT at high risk of developing

type 2 diabetes can prevent or delay disease onset

and improve their blood glucose through modest

improvements in diet and exercise. Of the over 3,200

participants in the DPP, 45 percent are from minority

populations that suffer disproportionately from type

2 diabetes—African Americans, Hispanic/Latino

Americans, Asian Americans, Native Hawaiians and

other Pacific Islanders, and American Indians/Alaska

Natives. All participants were overweight with

impaired glucose tolerance and were randomly

assigned to one of the following groups: intensive

lifestyle changes, treatment with the medication metformin, or a placebo control. The lifestyle intervention aimed to reduce weight by 7 percent through a

low-fat diet and exercising for at least 150 minutes

per week. Patients in the lifestyle intervention group

were 58 percent less likely to develop diabetes than

those in the control group. The lifestyle intervention

was effective for both men and women and in all of

the racial/ethnic groups. Lifestyle intervention also

worked well in people over age 60, reducing the

development of diabetes by 71 percent in this group.

Participants randomized to treatment with metformin reduced their risk of developing the disease

by 31 percent. The DPP was co-sponsored by NICHD,

the National Institute on Aging (NIA), the National

Center for Minority Health and Health Disparities

(NCMHD), NCRR, the NIH Office of Research on

Women’s Health (ORWH), and the Office of Behavioral

and Social Science Research (OBSSR). CDC, ADA, and

industry provided additional support.

A post-DPP study will enable investigators to 

continue a long-term followup of the DPP cohort.

Another clinical trial of great significance to type 2

diabetes is “Look AHEAD—Action for Health in

Diabetes.” This large, multicenter trial is designed to

determine whether interventions to produce sustained weight loss in obese individuals with type 2

diabetes will improve health. The trial is expected to

recruit a patient population whose overall ethnic and

racial composition will reflect the prevalence rates

for diabetes in the U.S. NIDDK is sponsoring this trial

along with the National Heart, Lung and Blood

Institute (NHLBI), the National Institute of Nursing

Research (NINR), NCMHD, ORWH, and CDC.

It is well recognized that there are major differences

in the prevalence of type 2 diabetes among racialethnic groups in the U.S. A research solicitation entitled, “Racial and Ethnic Differences in the Etiology 

of Type 2 Diabetes in Minority Populations,” will

determine, through studies in representative U.S.

populations, the reasons for disparities in the 

incidence of type 2 diabetes in minority racial-ethnic

populations. Additionally, information that could

emerge from these studies would be important for

devising cost-effective approaches to phenotyping

patients with type 2 diabetes and individuals at risk

for the disease.
DMICC ANNUAL REPORT 30 FY 2001

Type 2 Diabetes in Children. Type 2 diabetes has 

traditionally been considered a disease of adults

because the age of onset is frequently after age 40

and it is often associated with obesity. Children with

diabetes usually have been presumed to have type 1

diabetes; however, in recent years, an increasing

number of children who appear with elevated blood

glucose levels are being diagnosed with type 2 

diabetes. The increase in reports of type 2 diabetes

among children parallels a similar rise in the adult

population, as obesity has become a major public

health concern. In children, the increased incidence

of type 2 diabetes appears to be occurring largely 

in minority populations—Hispanic/Latino Americans,

African Americans, and Native Americans—again

paralleling the disproportionate burden this disease

places on the same minority populations in 

adulthood.

To combat type 2 diabetes in children, NIDDK, along

with NICHD, is supporting research to promote

greater understanding of its causes, to refine diagnostic criteria, to define metabolic abnormalities, and

to formulate treatment options. In addition, NIDDK

has recently awarded support for a coordinating center and clinical centers to develop community- or

school-based primary prevention programs that can

be applied in a cost-effective manner to decrease the

risk factors for type 2 diabetes and to reduce the

incidence of this disease in children and adolescents.

Treatment options will be studied to determine the

safest, most effective, and cost-effective strategies to

achieve and maintain normal blood glucose levels in

the pediatric population.

Genetics of Diabetes and Its Complications. Diabetes

and its complications have strong genetic determinants. Even though diabetes appears to develop as a

result of many factors, virtually all forms appear to

have genetic influences, with the likely involvement

of multiple genes. NIDDK is involved in major initiatives to capitalize on new knowledge about the

human genome and the genetics of diabetes. The

Institute is a leading partner in support of the

International Type 2 Genetic Linkage Analysis

Consortium. The purpose of the Consortium is to

combine data from multiple genome scans and thus

increase the probability of gene discovery. The

groups involved in the Consortium are pursuing a

fine mapping effort of potential susceptibility genes

for type 2 diabetes located on several chromosomes.

Intensified support for the Consortium will also permit additional analyses to determine whether unique

susceptibility genes exist in African Americans, who

are disproportionately affected by type 2 diabetes.

NIDDK and JDRF are working closely to establish 

a Type 1 Diabetes Genetics Consortium. The initial

objective would be to pursue the results of three

genome-wide scans for type 1 diabetes, which have

recently been completed. These scans have identified

several genetic regions as likely to contain diabetes

susceptibility genes. A combined analysis of these

three datasets could identify the most promising

areas for further study of genes that confer susceptibility to type 1 diabetes.

To identify the genes responsible for the kidney complications of diabetes, the Institute is now launching

a new genetics initiative called “FIND”—the Family

Investigation of Nephropathy and Diabetes. This initiative will focus on family studies designed to

uncover candidate genes associated with type 1 or

type 2 diabetes, genes associated with development

of complications, and genes relevant to those identified in animal models. A specific objective will be to

search for susceptibility genes in subpopulations of

Caucasians, African Americans, Hispanic/Latino

Americans, and American Indians/Alaska Natives

across the U.S.
DMICC ANNUAL REPORT 31 FY 2001

In FY 2001, NIDDK issued a solicitation to establish

a cross-disciplinary Mouse Models of Diabetic

Complications Consortium that will develop innovative mouse models of diabetes complications that

closely mimic human disease. The consortium will

generate animal models that will be useful for the

study of disease pathogenesis, prevention and treatment and test the role of candidate genes or chromosomal regions that emerge from genetic studies of

human diabetic complications, particularly diabetic

kidney disease and accelerated cardiovascular 

disease. When a model is sufficiently characterized

and validated, the mice will be distributed to the

research community for individual investigatorinitiated projects.

Complications of Diabetes. The complications of diabetes affect virtually every system of the body.

Diabetes is the leading cause of kidney failure, new

blindness in adults, and non-traumatic amputations.

It is a major risk factor for heart disease, stroke, and

birth defects; shortens average life expectancy by up

to 15 years; and costs the nation in excess of $100

billion annually in health-related expenditures.

NIDDK is undertaking several new and expanded initiatives designed to further understanding of the key

mechanisms involved in development of the complications of diabetes and the means to reduce or prevent them. Some examples of research solicitations in

this area follow.

Diabetes is the leading cause of non-traumatic lower

extremity amputations in the U.S. Foot ulcers are a

major predictor of future amputation in patients

with diabetes. Even without amputation, diabetic

foot ulcers contribute a major economic burden to

society and impair quality of life for the individual.

Despite advances in wound care, the incidence of diabetic foot ulcers, and of amputations, remains high.

An initiative entitled “New Therapies for Diabetic

Foot Disease” encourages research on the etiology

and pathogenesis of diabetic foot ulcers and development of effective prevention and treatment modalities. It is hoped that this solicitation will lead to new

diagnostic, prognostic, and therapeutic strategies to

reduce the burden of diabetic foot disease. NINR is

also supporting this initiative.

Extant information on the incidence of complications

in the U.S. is often based on community populations

or large clinic populations in which the onset of diabetes occurred several decades ago. These studies

generally found a striking and large excess of

microvascular disease in minority racial and ethnic

groups, including American Indians/Alaska Natives,

African Americans, Hispanic/Latino Americans, Asian

Americans, Native Hawaiians and other Pacific

Islanders. Whether these disparities in diabetes complications continue to occur in contemporary diabetic patients is not known. A solicitation entitled

“Race/Ethnic Disparities in the Incidence of Diabetes

Complications” will investigate differences among

contemporary populations in the U.S., categorized by

race, ethnicity, and other factors, in risk factors for

the development and rates of complications in diabetes. Research supported through this initiative

may also aid in determining the extent to which

other factors, including metabolic and genetic variations, medical care, socioeconomic status, and behavior account for these differences.

Over 60 percent of individuals with diabetes suffer

from some form of neuropathy, and in many patients

the symptoms are serious enough to interfere with

daily activities. Diabetic peripheral neuropathy is

often associated with peripheral vascular disease

and impaired wound healing. Symptoms of diabetic

autonomic neuropathy can include heart rate abnormalities, blood pressure dysregulation, dizziness,

digestive disturbances, and impotence. Autonomic

neuropathy is thought to be an important cause of

sudden cardiac death in patients with diabetes.

Effective therapies for the prevention and treatment

of diabetic neuropathy are not currently available. An

initiative sponsored by the National Institute of

Neurological Disorders and Stroke (NINDS), and supported by NIDDK and JDRF, may lead to increased

understanding of the mechanisms by which diabetes

results in painful, disabling peripheral neuropathy,

autonomic neuropathy, impaired counterregulation

and hypoglycemia unawareness, and other neurologi-
DMICC ANNUAL REPORT 32 FY 2001

cal complications. It is the intent of this initiative to

attract basic neuroscientists to the study of diabetic

neuropathy and neurobiology relevant to diabetes

and enhance interdisciplinary approaches to

research in this area.

In November 1999, NIDDK, NIAID, NHLBI, NCRR,

JDRF, and ADA sponsored a meeting entitled, “Gene

Therapy Approaches for Diabetes and Its

Complications.” One of the recommendations from

the meeting was to support additional studies to

develop novel approaches using gene therapy for the

treatment of diabetes and its complications. There

are many approaches to interfering with the development of type 1 diabetes and to treating the complications resulting from both type 1 and type 2 diabetes

that would appear to be amenable to gene therapy

technology. A solicitation spearheaded by NIDDK also

encourages development of gene therapy approaches

for type 1 diabetes and its complications and to their

application in appropriate animal models or small

pilot studies.

Prevention and treatment of long-term complications

remain critical problems in the management of both

type 1 and type 2 diabetes. Identification of patients

at risk for the development of complications, with

the hope of early intervention, is a public health priority. Early intervention is essential, because by the

time symptoms of disease are recognized, irreparable

damage to organs may have already occurred.

NIDDK, in collaboration with the National Eye

Institute (NEI) and NINDS invites basic and clinical

research to develop biochemical, cellular, physiologic,

and genetic surrogate endpoints that can be used to

predict risk, aid in early diagnosis, and assess the

progression of complications of diabetes. The overall

aim of this solicitation is to develop biomarkers that

could be used as diagnostic tools for the individual

patient, or as outcome measures to be used in clinical trials testing new therapeutic agents.

In the U.S., diabetes is the leading cause of new cases

of end stage renal disease. Large-scale interventional

trials have established that blockade of the reninangiotensin system and good glycemic control both

slow the progression of diabetic kidney disease.

Nonetheless, many patients with diabetes develop

progressive kidney disease in spite of adequate management of these factors, and new strategies, both to

prevent disease and to slow its progression, are

needed urgently. NIDDK has issued a solicitation for

clinical research trials using novel agents or drug

combinations in patients to prevent the appearance

or slow the progression of diabetic kidney disease.

The goal of this initiative is to evaluate therapies

that might potentially be taken to large, phase III

interventional trials.

Bench-to-Bedside—Translation of Research into

Clinical Practice. One initiative, spearheaded by

NIDDK, will support partnerships between clinical

and basic biomedical researchers with the goal of

translating advances in understanding of the molecular basis of type 1 diabetes and its complications

into new therapies for the prevention, treatment, and

cure of this disease. In the “bench to bedside”

research partnerships, a team of clinical and basic

scientists will conduct collaborative research that, if

successful, will bring basic research advances from

the laboratory to a point where potential new therapy can be tested in patients or in preclinical studies

in animal models.

Education and Outreach.

Refer to NDEP Section (pg. 45)
DMICC ANNUAL REPORT 33 FY 2001

Diabetes has long been used in teaching biomedical

sciences as a model for understanding the physiology

and cell biology of organ systems, since it affects so

many systems. Diabetes is an especially relevant

model for teaching biology to younger students, particularly in communities adversely impacted by the

disease. Moreover, education focused on diabetes

could serve several purposes in such communities,

such as fostering science education, encouraging students to select science and health-related career

paths, and providing information that may influence

healthy lifestyle choices in children and families at

risk for diabetes. Through this, Tribal youth can be

instrumental in preventing the development of and

promoting better management of diabetes for themselves and in their own communities. A recent solicitation resulted in support for seven Tribal Colleges 

or Universities for planning grants to develop educational programs to enhance understanding and

appreciation of diabetes and related science in elementary, middle and high schools serving American

Indian/Alaska Native communities.

National Institute of Environmental Health

Sciences (NIEHS)

Many environmental agents have been investigated

as contributing to the risk of type 1 diabetes.

Environmental components have been suggested

because concordance rates between identical twins,

where one twin has type 1 diabetes, remain at 30 to

50 percent. NIEHS is pursuing research in several

areas relevant to the etiology of type 1 diabetes,

as summarized below.

Current Activities

Recent studies have raised the possibility that certain chemicals in the environment, such as nitrates

in well water, increase the risks of juvenile diabetes.

Studies in the United Kingdom, Finland, and

Colorado indicate that the incidence of childhood

diabetes is higher in areas with elevated levels of

nitrate in the drinking water. This finding is significant for agricultural communities because well 

water can have elevated nitrate levels in areas where

there is extensive use of fertilizers. Current and

future activities in this area by NIEHS intramural

scientists include:

• Further investigation of the possible association

between nitrates and juvenile diabetes in a rigorous

prospective study, such as the Agricultural Health

Study.

• Evaluation of diabetes along with other health 

outcomes in the Agricultural Health Study.

In other studies, intramural investigators at NIEHS

have reported an association between the body burden of a persistent organic pollutant (polychlorinated

biphenyls) and type 1 diabetes. Current and future

studies in this area include further studies to examine the relation between diabetes and body burden of

persistent organic pollutants are either underway or

being planned. For example, DNA is being collected

from a cohort of men so that polymorphisms in the

Ah-receptor (binds with dioxin-like polychlorinated

biphenyls) can be examined in relation to body burden of persistent pollutants and risk of diabetes.
In extramural studies supported by NIEHS, investigators are studying the possibility that arsenic in

drinking water causes an increase in diabetes risk.

Elevated levels of arsenicals in drinking water are

common throughout the world, and oxidative forms

of arsenic are known to have cytotoxic effects.

These studies will:

• Investigate the effects of trivalent arsenicals and

related compounds on glucose- stimulated insulin

secretion in pancreatic islets and cell culture 

systems.

• Examine the effects of these compounds on insulin

sensitivity in insulin-sensitive peripheral tissues

and in intact animals.

NIEHS intramural investigators are also investigating the role of menstrual and reproductive risk 

factors in diabetes and are looking at mechanisms 

of how environmental agents can affect pancreatic

cancer cells.

National Institute of General Medical Sciences

(NIGMS)

The National Institute of General Medical Sciences

supports research and research training in the basic

biomedical sciences that provide the foundation for a

better understanding of fundamental life processes.

Some of this work has relevance to understanding

and treating diabetes.

Current Activities

NIGMS supports the Human Genetic Cell Repository,

a collection of over 6,600 cell lines from individuals

with a wide variety of genetic disorders, including

diabetes, and from normal individuals. Cell lines in

the collection include those from individuals with

various types of diabetes, including insulin-dependent diabetes mellitus (IDDM) and diabetes mellitus

and insipidus with optic atrophy. The repository

includes an extensive collection of cell lines from

members of an extended pedigree with maturityonset diabetes of the young. This collection is of

value in studies designed to map and characterize

the gene(s) responsible for the disorder.

NIGMS has an interest in understanding how genetic

and environmental components interact to result in

complex diseases such as diabetes. The Institute supports a portfolio of grants to develop better statistical methods for mapping and identifying genes

underlying complex traits, to develop mathematical

models for studying gene-gene and gene-environment

interactions, to investigate DNA sequence variation

and its evolution, to examine gene activities and the

consequences of abnormalities in these activities,

and to optimize sampling strategies. NIGMS also

supports pre- and postdoctoral training that emphasizes statistical and computational skills and workshops to provide additional training in statistical

methods to biologists.

NIGMS support for research on the mechanisms

underlying individual variations in drug response,

while not specifically targeting diabetes, has the

potential to have an impact on the treatment of diabetes and its complications. Researchers are studying the structural features of a powerful peripheral

vasodilator related to insulin identified as an important prospective drug for peripheral angiopathies

associated with diabetes.

DMICC ANNUAL REPORT 34 FY 2000
DMICC ANNUAL REPORT 35 FY 2001

NIGMS, in conjunction with several other Institutes,

is supporting a mouse mutagenesis and phenotyping

center whose emphasis is the high-throughput generation and identification of mice with mutations in

developmental defects, including those that affect

organogenesis.

NIGMS is also participating in the Trans-NIH

Zebrafish Initiative, whose goal is to improve the

genomic resources for the zebrafish, a potentially

valuable model for diabetes.

For many of the cell lines in the Human Genetic Cell

Repository, DNA is also available. In a major new 

initiative, the Repository has cooperated with the

National Human Genome Research Institute to acquire

a collection of cell lines, and DNA, from 500 unrelated individuals representative of the diversity of the

U.S. population. This resource has already been of

great value to researchers for the discovery of DNA

polymorphisms, an important step in identifying

genes involved in complex genetic disorders such 

as diabetes.

Future Activities

In the future, NIGMS will continue to support basic

research that focuses on underlying mechanisms 

and principles that are expected to shed light on

both normal and disease processes and to lead to 

the development of new modes of treatment and 

prevention.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health (NIMH) 

supports research on the processes and mechanisms

underlying co-morbid mental disorders and diabetes.

It also supports research to develop and test preventive, treatment, and rehabilitative interventions for

mental disorders in people with diabetes—the interventions may be pharmacologic, behavioral, or 

psychosocial.

Current Activities

In FY 2000–2001, NIMH and the National Institute of

Diabetes and Digestive and Kidney Diseases (NIDDK)

co-sponsored a major research conference,

“Depression and Mental Disorders in Patients with

Diabetes, Renal Disease, and Obesity/Eating

Disorders,” on January 29–30, 2001 at the Natcher

Conference Center, National Institutes of Health. The

papers resulting from the conference are currently

in preparation for journal publication in 2002.

Future Activities

NIMH and NIDDK have jointly released a Request for

Applications with a set aside of $1.5 million to fund

new research projects in FY 2002. In addition, NIMH

will re-issue in FY 2002, its program announcement

calling for research applications on co-morbid 

mental and physical disorders, including diabetes.
DMICC ANNUAL REPORT 36 FY 2001

National Institute of Neurological Disorders 

and Stroke (NINDS)

The National Institute of Neurological Disorders and

Stroke supports a portfolio of research to study the

neurological complications of diabetes. Over 60 percent of people with diabetes are affected by neuropathy, and in many patients symptoms such as pain,

numbness, weakness, or even paralysis are serious

enough to interfere with daily activities. Symptoms

of diabetic autonomic neuropathy can include heart

rate abnormalities, hypertension, dizziness, digestive

disturbances, and impotence. Autonomic neuropathy

is an important cause of sudden cardiac death in

people with diabetes. Prevention and treatment of

neurological complications is a central therapeutic

problem in diabetes mellitus, as well as ancillary

research in the areas of metabolism, sensory disorders, impaired wound healing, and pain.

Current Activities

NINDS has participated in nine initiatives related 

to the type 1 diabetes appropriations, three as the

lead Institute. As the result of three RFAs (Requests

for Applications) published each year between FY

1998 and FY 2000, NINDS has greatly expanded its

research into neurological complications of diabetes.

New areas of study include early detection of diabetic neuropathy, gene transfer for prevention of neuropathy, autonomic neuropathy, behavioral effects of

hyperglycemia, and mechanisms of neuropathic pain.

NINDS continues to support a large epidemiological

study of neurological complications of diabetes in

the Rochester, Minnesota, area in the Caucasian and

Mdewakanton Dakota Native American populations.

Future Activities

In FY 2002, applications in response to a new RFA,

“Effects of Hypoglycemia on Neuronal and Glial Cell

Function,” will be received. This RFA solicits basic

studies (1) to define the effect of varying glycemic

levels on cerebral metabolism, transport of glucose

across the blood brain barrier, and astrocytic regulation of substrates for neuronal metabolism, and (2) to

determine pathological consequences of acute and

recurrent hypoglycemic insult on cells of the central

nervous system.

In addition to the Caucasian and Mdewakanton

Dakota Native American populations, the Rochester

epidemiological study will be expanded to include

Hispanic subjects. Diabetes is characterized by large

disparities in prevalence among ethnic groups, but

little is known about the extent of neurological complications in these populations. This study will be 

the first to document the extent and progression 

of neurological complications in a longitudinal 

multiethnic cohort.

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research supports

and conducts research and research training on the

biological and behavioral processes that underlie

promotion of health, amelioration of illness and its

sequelae, and effective delivery of care. One purpose

of this research, specific to diabetes, is to understand

how to promote health-sustaining behavior and to

improve quality of life by relieving the effects of 

disease processes and their progression. Nursing

research focuses on how physical and psychological

responses to diabetes symptoms and treatment of

the disease affect health throughout the lifespan.

NINR research programs pay particular attention 

to special populations affected by diabetes.
DMICC ANNUAL REPORT 37 FY 2001

Current Activities

In response to three Program Announcements (PAs)

either directly or indirectly related to diabetes

research, NINR had a significant increase in diabetes

funding in FY 2000 and FY 2001. The three PAs were

published in January and June of 2000. Two were

specific to diabetes research and the third included

diabetes research opportunities.

The announcements were “Enhancing Adherence to

Diabetes Self-Management Behaviors,” “Diabetes SelfManagement in Minority Populations,” and “SelfManagement Strategies Across Chronic Diseases.”

These PAs are consistent with the congressionally

mandated Diabetes Research Working Group (DRWG)

recommendations (NINR was a participant in this

working group).

In response to increased congressional support for

type 1 diabetes research, NINR also joined three

requests for applications: “Innovative Partnerships in

Type 1 Diabetes Research,” “New Approaches to

Prevent Hypoglycemia in Patients with Diabetes,” and

“Understanding Hypoglycemia Unawareness in

Patients with Diabetes.”

Funded grants related to diabetes research included

career development, postdoctoral training, and

research. Diabetes-specific topics included ethnic

variations in type 2 diabetes prevention knowledge,

cardiac risk factors in type 1 and 2 adolescents,

autonomy and self-care in type 1 adolescents,

Spanish language self-management programs, intervention studies in several ethnic groups, a description of the integration of diabetes self-care in

Mexican-Americans with type 2 diabetes in the

southwest, an intervention for parents of young children with newly diagnosed diabetes, biophysical

determinants of diabetes foot ulcer healing, weight

loss in diabetes, and children’s response when a sibling has type 1 diabetes.

Future Activities 

NINR plans to continue to support research that

focuses on problems experienced in diabetes populations. Research efforts will be guided by the following goals:

• FY 2002: NINR plans to focus support on 

promising ongoing and new diabetes research

areas, while building on recent nursing science

advances.

• FY 2003: NINR will work collaboratively with 

other Institutes and organizations to increase and

facilitate diabetes research activities.

In summary, NINR activities are designed to 

support research related to diabetes interventions,

self-management, quality of life, special and diverse

population needs, problems of defined age groups

and across the lifespan, basic research, genetics,

and other initiatives relevant to clinical practice 

and client outcomes. Advances in science leading to

translation to the practice setting will be encouraged.

National Institute on Aging (NIA)

The mission of NIA as it relates to diabetes research

and related issues is to support biomedical and

behavioral research leading to improved therapies 

to prevent diabetes and its complications, as well as

improved quality of life of older diabetic patients.
DMICC ANNUAL REPORT 38 FY 2001

Current Activities

NIA continues to support studies of potential metabolic mechanism(s)/factors that contribute to and/

or underlie deleterious changes in body composition

that can lead to metabolic disorders in old age.

Ongoing studies in animal models have found that

surgical removal of visceral fat results in increased

insulin sensitivity similar to that seen with caloric

restriction. It has also been noted that insulin-mediated suppression of hepatic glucose production during hyperinsulinemia is diminished with aging in ad

lib fed rats. By preventing an increase in visceral fat,

or fat mass, or with caloric restriction, there can be

marked improvement in the ability of insulin to suppress hepatic glucose production.

Ongoing clinical studies are focusing on the development of interventions to reduce abdominal fat and 

on the factors mediating regional differences in body 

fat noted in older NIDDM patients.

Insulin resistance is a metabolic disorder that may

precede the development of type 2 diabetes in older

adults. Ongoing studies in aging rats have shown

that insulin resistance is characterized by elevated

insulin release as well as increased glucose effectiveness (the latter reflecting primarily enhanced hepatic

action of glucose to suppress endogenous glucose

production).

It also appears that free fatty acids (FFA) play a 

key role in endogenous glucose production. Acute

glucose elevation induces a marked decline in plasma

FFA. Such findings suggest that at basal insulin,

inhibition of endogenous glucose production by

hyperglycemia may be mediated by glucose-induced

suppression of FFA.

NIA was a cosponsor of the National Institute of

Diabetes and Digestive and Kidney Diseases (NIDDK)

and DMICC workshop, “Diabetes and Aging, From

Basic Biology to Clinical Care: New Research

Directions for Understanding Diabetes in Older Age.”

NIA was also a cosponsor of the NIDDK study,

Diabetes Prevention Program (DPP).

NIA participated in the DMICC Task Force to 

develop a Diabetes Prevention Initiative.

Future Activities

Data from animal models suggest that caloric restriction (CR) can prevent and/or delay the onset of agerelated pathologies, including insulin insensitivity.

Moreover there are data that demonstrate that physical activity can decrease body weight and body fat

comparably to CR and have similar effects on glucose tolerance and insulin sensitivity, but physical

activity has significantly less effect on life span.

In March 1999, NIA and NIDDK co-sponsored the

meeting of the Caloric Restriction Clinical

Implications Advisory Group. Based on the scientific

recommendations from the Caloric Restriction

Advisory Group, NIA issued the Request for

Applications (RFA), “Exploratory Studies of Sustained

Caloric Restriction in Non-Obese Persons:

Physiologic Effects and Comparisons/ Interactions

with Physical Activity.” Briefly, the purpose of this

RFA was to solicit applications for cooperative agreements (U01s) for exploratory controlled human intervention studies on the effects of caloric restriction

(CR) interventions on physiology, body composition,

and risk factors for age-related pathologies in nonobese persons. Studies of similarities, differences,

and/or potential interactions between the effects of

CR and of physical activity (PA) on these outcomes

were also invited. Three sites will be awarded from

this RFA, and this group of U01 projects will be

known as CALERIE (Comprehensive Assessment 

of Long-Term Effects of Reducing Intake of Energy).

It is anticipated that the CALERIE studies will 

begin in early 2002.
DMICC ANNUAL REPORT 39 FY 2001

National Institute on Alcohol Abuse 

and Alcoholism (NIAAA)

The National Institute on Alcohol Abuse and

Alcoholism encourages research to understand the

role of alcohol consumption as a risk factor in the

development of diabetes mellitus. NIAAA also supports research to determine the effects of moderate

alcohol consumption on diabetes. Several studies

suggest that alcohol consumption may directly or

indirectly contribute to the development of type 1

diabetes. This contention is based on following

observations: (a) alcohol may impair the release of

insulin from the pancreas; (b) chronic alcohol intake

can increase plasma levels of TNF, which has been

shown to cause apoptosis of pancreatic beta cells

that in turn may decrease beta cell number and

insulin secretion; and (c) chronic alcohol consumption may impair beta cell function by eliciting

immunotoxicity.

Chronic alcohol consumption also has been implicated in the development of type 2 diabetes based on

the following findings: (a) chronic alcohol feeding in

rats reduces the number of insulin binding sites on

isolated hepatocytes; (b) alcohol impairs insulinmediated tyrosine phosphorylation of insulin receptors in a tumor cell line; (c) chronic alcohol exposure

blunts tyrosine phosphorylation of insulin receptor

substrate-1 in rat hepatocytes and a tumor cell line;

and (d) chronic alcohol exposure inhibits the activity

of rat hepatocyte phosphotidylinositol-3kinase,

which stimulates glucose transport. These effects of

alcohol may lead to insulin resistance and impaired

glucose transport.

Current Activities

Currently, NIAAA supports three projects that 

investigate the relationship between alcohol intake

and diabetes. The following research areas are 

under investigation:

• Impact of moderate alcohol consumption on 

the risk of diabetes mellitus.

• Effects of fetal alcohol exposure on the biochemical

and physiological changes in the insulin response

and glucose homeostasis.

• Molecular mechanisms of disruption of insulinmediated glucose transport by ethanol.

National Library of Medicine (NLM)

In particular, NLM seeks to learn how the use of

NLM’s MEDLINEplus Web site, and other computerbased health information resources, can be helpful to

patients, their families, and members of the public to

learn about and understand the latest research news

on diabetes, nutritional requirements, tests, devices,

secondary prevention techniques, and for obtaining

answers to patient-specific questions.

In the clinical setting, the principal hypothesis is

that MEDLINEplus can reinforce and supplement 

the information provided by physicians, nurses,

and health educators. A related hypothesis is that a

combination of individualized training and access 

to publicly available computer resources at hospital

libraries and elsewhere in the community can help

bridge the “digital divide” experienced by minority

populations who have less ready access to computers

in the home, school, and workplace than the majority

population.
DMICC ANNUAL REPORT 40 FY 2001

Current Activities

NLM’s objectives are to develop, design, implement,

and evaluate a comprehensive program of diabetesfocused outreach initiatives in collaboration with

academic health science centers and libraries, clinical centers, community-based organizations, and 

voluntary health organizations.

Project A. In collaboration with the Naomi Berrie

Diabetes Center at Columbia/Presbyterian Hospital

in New York City, this project studies the benefits of

MEDLINEplus and the Center’s own Web site with

Hispanic and African-American teenage type 1 diabetes patients who are on the insulin pump. These

new resources are intended to reinforce and supplement the information provided by the Center’s physicians, nutritionists, and educators. The Center is also

working with the medical informatics department at

Columbia to build a type 1 diabetes module for a

promising telemedicine system now under development for patients and hospital staff.

Project B. In collaboration with the Children's

Hospital of Los Angeles, this project studies how a

diverse patient population of Hispanic and AfricanAmerican teens and the families of newly diagnosed

type 1 patients can benefit from using MEDLINEplus

to learn about and understand the latest research

news, nutritional requirements, and uses of new

medical devices for promoting better diabetes management and control.

Project C. In collaboration with the Medical

University of South Carolina health sciences library,

this project studies how third-year medical students

and their preceptors equipped with portable laptop

computers can use the technology to access needed

diabetes and other health information at the time of

need. The students are enrolled in a clerkship that

serves rural indigent patients, many of whom suffer

from type 2 diabetes and its complications.

Project D. This study will provide a followup with 

the King/Drew Medical Center in Los Angeles and

their efforts to promote continuity of care with the

aid of a diabetes “smart card” that enables access to

a centralized medical record and diabetes-related

test results for a type 2 Hispanic and AfricanAmerican population that is seen variously at different health centers across the county.

Project E. In collaboration with the University of

Texas Health Science Center at San Antonio, and at

its regional health center and clinics in the Lower

Rio Grande Valley, this project studies how a computer workstation installed in the clinic waiting room

can provide Hispanic patients with diabetes-related

information. To encourage use of MEDLINEplus, the

health care providers will use prescription pads.

Project F. This project will collaborate with the

Juvenile Diabetes Research Foundation International

(JDRF) in a variety of mutually supportive uses of

new information technologies. These include

enhancement of NLM’s MEDLINEplus diabetes content for children and teens; user evaluations of

MEDLINEplus; inclusion of JDRF-sponsored trials in

NLM’s ClinicalTrials.gov database; creation of

Spanish language resources based on JDRF’s

Countdown research magazine; experimentation with

informatics tools to lessen the probability of misdiagnosis of type 1 diabetes, particularly in emergency

departments serving minority and other medically

underserved populations; and experimentation with

informatics and distance education tools for science

teachers and nurses in low income high schools.
DMICC ANNUAL REPORT 41 FY 2001

The Veterans Health Administration (VHA),

Department of Veterans Affairs

The mission of the Veteran's Healthcare System is to

serve the needs of America's veterans by providing

primary care, specialized care, and related medical

and social support service. To accomplish this mission, VHA needs to be a comprehensive, integrated

healthcare system that provides excellence in healthcare value, excellence in service as defined by its customers, and excellence in education and research,

and it needs to be an organization characterized by

exceptional accountability and by being an employer

of choice.

The mission of the VHA diabetes program is to

improve the health of veterans with diabetes by

decreasing the incidence of adverse health outcomes,

especially macrovascular and microvascular disease.

This will be accomplished through systems-level

integration of guidelines, performance measurement,

and data feedback to promote the increased use of

evidence-based preventive and treatment processes.

VHA research service supports this mission through

clinical, basic science, and health services research.

VHA reports the following progress in FY 2001:

Current Activities

Performance Measurement (Office of Quality and

Performance, OQP). In FY 2001, VHA, through its

External Peer Review Program, collected data from 

a random sample of 40,095 charts of veterans with

diabetes. Eligible patients must have accessed VHA

for care some time during the previous 12 months.

OQP data analysis showed that the percentage of

patients having chart documentation of the following

Diabetes Quality Improvement Project (DQIP) measures using DQIP abstraction criteria within 12

months (or as noted) of chart review is as follows:

• HbA1c test (93%); 80% of HbA1c values less than

9.5%; 61% less than 8.0%; 38% less than 7%.

• Lipid profile within 2 years (91%); 68% of LDL–C

values less 130 mg/dl, 40% less than 100 mg/dl.

• Blood pressure control, 55% less than 140/90.

• Dilated retinal examination (66%).

• Nephropathy screening within 2 years (72%).

• Visual examination of feet (91%); palpation of pedal

pulses (83%); sensory examination of feet (78%);

referral of patients with “high risk feet” to a foot

care specialist (85%).

Since VHA uses DQIP measures, comparison to the

private sector is possible. FY 2000, VHA national

adherence to most measures was at the 90th percentile of the individual private sector plans included

in the NCQA Quality Compass Report.

VHA Diabetes Registry (Office of Policy and

Planning). VHA has developed a nationwide diabetes

registry derived from administrative data. Veterans

are identified as having diabetes using one inpatient

or two outpatient codes with a diabetes-specific

code, or receipt of an oral agent or insulin. The

denominator is defined as veterans who had at least

one clinical visit during the year. For FY 2000,

639,323 veterans with diabetes were identified out of

3, 318,158 veteran users, yielding a prevalence of 19.3

percent. This cross-sectional calculation technique

probably yields an underestimate compared to the

prevalence calculated from a longitudinal analysis.

Based on registry data analysis, the mean HbA1c 

for FY 2000 was 7.61%; and the mean LDL–C was 108

mg/dl. In addition to cardiovascular disease, the

cohort had a high prevalence of co-morbid conditions,

including about 30 percent mental health conditions,

which is an underreport if one considers self reports

as the reference standard.
DMICC ANNUAL REPORT 42 FY 2001

Lower Extremity Amputation Programs (Offices of

Policy and Planning and Patient Care Services). In

collaboration with the Centers for Disease Control

and Prevention Division of Diabetes Translation, a

12-year Lower Extremity Amputation (LEA) Registry

has been created by the Office of Policy and Planning.

From FY 1997–FY 2000, the age-adjusted rate (standardized to the VHA 1998 User Population) of LEA 

in the entire veteran population has decreased from

2.18 (0.78 major amputations [e.g., below knee or

above knee]) to 1.42 (0.65 major amputations) per

1000 VHA users in FY 2000.

On May 11, 2001, the Under Secretary for Health 

reissued the VA Preservation, Amputation Care, and

Treatment Directive (PACT), which mandates multidisciplinary foot care programs, including screening,

surveillance and salvage components, at all VHA

facilities.

VHA recently participated as a full partner with 

the American Diabetes Association, the Centers for

Medicare and Medicaid Services (CMS), the American

Podiatric Medical Association and the Centers for

Disease Control in an initiative to improve foot care

for Medicare beneficiaries with diabetes. CMS’s 

comprehensive decision memorandum cites five VHA

research papers as providing scientific evidence to

support the requested coverage benefit. The results 

of the VA PACT Program were also submitted as 

evidence.

Guideline Development (Offices of Quality and

Performance and Patient Care Services). VHA, in

partnership with the Department of Defense, issued a

revision (2/00) of its Diabetes Clinical Practice

Guidelines. The guidelines, covering outpatient management of glycemia, blood pressure, hyperlipidemia,

diabetic retinopathy, foot care, and renal disease,

emphasize transparency of the evidence underlying

clinical recommendations as well as principles of

absolute risk reduction and patient-clinician target

(HbA1c) value negotiations. Version 1.0 was developed in collaboration with the executive committee

of the National Diabetes Education Program. VA has

developed concise, pocket-size clinical guideline

information for nationwide distribution.

Research Service. There are three VA Diabetes

Centers of Excellence focused on diabetes research

co-funded by Medical Research Service and the

Juvenile Diabetes Research Foundation International.

Investigators at these sites are investigating the

effects of diabetes on the vascular system; mechanisms of insulin resistance; cellular and molecular

processes by which intensive therapy reduces insulin

resistance; the role of exercise in modulating the

effectiveness of therapy; and mechanisms responsible for defective low blood sugar regulation.

VHA funded a 5-year cooperative study (VA Diabetes

Trial (VADT), CSP #465) to evaluate the effect of nearnormal glycemic control on cardiovascular outcomes

in type 2 diabetes. VADT will enroll 1,700 men and

women from 20 VHA sites randomized to intensive

versus conventional control. The outcome will be

assessed by evaluating composite cardiovascular

events.

The VHA Quality Enhancement Research Initiative

(QUERI) has been cited as a model by the Institute of

Medicine. The goals of QUERI initiatives are to translate research into improvements in patient care and

outcomes. The primary focus of the Diabetes

Mellitus-QUERI program is on more aggressive treatment of modifiable risk factors and the prevention of

progressive complications among veterans with diabetes. These activities range from the implementation

of interventions to assist “front-line” clinicians with

targeting high-risk patients to the design and evaluation of alternate methods for constructing diabetes

care quality indicators. QUERI–DM is also working

with partners outside VA, including the Centers for

Disease Control and Prevention (Translating

Research into Action for Diabetes). This project will

produce a structural and organizational analysis of

VHA diabetes care and allow direct comparisons

with diabetes care in the private sector.
DMICC ANNUAL REPORT 43 FY 2001

Joslin Vision Eye Network (Office of Patient Care

Services). The VHA is a participant in the

Telemedicine Project for Non-Mydriatic Retinal

Examination in partnership with the Joslin Vision

Network. The Joslin Vision Network is a congressionally mandated project, which currently includes the

VHA, the Department of Defense, and the Indian

Health Service. The project involves imaging the retina with a non-mydriatic camera and transmitting the

images to a reading center. VHA has established centers in the New England and North West regions and

is planning further expansion to the Sunbelt region.

A recent VHA teleopthamology (digital imaging) consensus conference made recommendations on the

technical aspects of data acquisition.

Standardization of Glycated Hemoglobin Testing.

Consistent with a directive from the Under Secretary

for Health, all VHA facilities use methodology traceable to the Diabetes Control and Complications Trial

(DCCT) standard as recommended by the National

Glycosylated Hemoglobin Standardization Program.

Education. Thirty VHA facilities have obtained

American Diabetes Association recognition of their

patient education programs—more than any other

national system of health care. VHA hosted the 3rd

annual National Diabetes Symposium for over 250

endocrinologists and primary care clinicians, as well

as the annual VA Diabetes Educators Conference for

nearly 300 VHA clinician educators. These conferences represent an institutional commitment to

translating agency priorities and research findings

into results at the field level.

Future Activities

VHA remains committed to improving outcomes 

for veterans with diabetes. A nationwide approach 

to more aggressive blood pressure control, instituted

last year, remains a priority. Research service has

issued requests for proposals for research to 

improve eye care and blood pressure control. The

Under Secretary for Health, in the reissued PACT

directive, has directed that senior management

review network amputation rates. A national Webbased learning center is being pilot tested. VHA 

has a national Computerized Patient Record System

(CPRS), with clinical reminders, and improvements 

to CPRS to support all clinical care, including 

diabetes, are ongoing.
THE NATIONAL DIABETES EDUCATION PROGRAM
Fiscal Year 2001 Accomplishments

INTRODUCING THE NATIONAL DIABETES

EDUCATION PROGRAM

The National Diabetes Education Program (NDEP) is

jointly sponsored by the National Institute of

Diabetes and Digestive and Kidney Diseases (NIDDK)

and the Centers for Disease Control and Prevention

(CDC) and is a subcommittee of the DMICC. The program speaks to a national audience of people with

diabetes and their families, health care providers,

payers and purchasers of health care, health care

system policy makers, and the general public, including people with undiagnosed diabetes and those at

risk for the disease.

The NDEP’s efforts are aided by a Steering

Committee comprised of representatives from diabetes-related, health care, racial/ethnic, and voluntary service organizations. Federal liaisons to the

NDEP Steering Committee include several representatives from the DMICC. Members of the Steering

Committee also serve on NDEP work groups that provide direction and help implement NDEP initiatives.

The NDEP also has developed a Partnership Network

of about 200 organizations to help disseminate 

program messages through the mass media, community groups, and health systems serving people with 

diabetes. A new web site, called “Team Diabetes,”

has been launched to provide an interactive, online

site for NDEP partners to exchange resources and

information.

In June 2001, the NDEP published Changing the Way

Diabetes Is Treated, A Progress Report from 

the National Diabetes Education Program that

reviewed the NDEP’s accomplishments since its 

inception in 1997 through Fiscal Year 2000. This

booklet details the origins, development, activities,

and future priorities of NDEP and has been distributed widely in the diabetes community. To obtain

copies of this publication, please contact Joanne

Gallivan, Program Director, NDEP, NIH at

Joanne_Gallivan@nih.gov.

During FY 2001, NDEP supported a variety of activities to promote awareness about the importance 

of diabetes control and to add an important new

message about comprehensive diabetes care.

Highlights of NDEP’s activities during the past year

are summarized below.

NDEP Steering Committee 

The Steering Committee met twice--in October 2000

in Miami, Florida, and in April 2001, in Washington,

D.C. The purpose of the meetings was to coordinate

and advise on program policies, initiatives, and goals

and to help coordinate efforts. The April meeting was

planned to help coordinate efforts in conjunction

with the June launch of the NDEP Comprehensive

Care Campaign.

During FY 2001, the NDEP worked with the Steering

Committee to modify the program’s organizational

structure. A key outcome of that effort was the creation of an Operations Committee that will provide

guidance on strategic planning and address crosscutting issues and opportunities within the NDEP

work groups. Several Steering Committee members

also completed their term of service during the past

year and will be replaced with new representatives.

DMICC ANNUAL REPORT 47 FY 2001

THE NATIONAL DIABETES EDUCATION PROGRAM
DMICC ANNUAL REPORT 48 FY 2001

Mass Media Campaigns 

From June 1998, when NDEP launched its first PSA

campaign, through FY 2001, NDEP’s campaigns have

obtained well over $13 million in free advertising

time or print media space. The NDEP initiated several new mass media campaigns in FY 2001. NDEP carried out extensive market research prior to initiating

these campaigns and developed the materials in conjunction with appropriate NDEP Work Groups. The

program also provided ongoing support for continuing campaigns targeted to African Americans,

Hispanic/Latino Americans, American Indians, and

Asian Americans and Pacific Islanders.

The Jerry Stackhouse “Discipline and Control”

campaign featured a Detroit Pistons basketball player whose family has been hit hard by diabetes. The

TV, radio, and print ads addressed the importance 

of diabetes control and demonstrated a son’s social

support for his parents who have diabetes.

“It’s More Than Food, It’s Life!” is the theme of 

FY 2001’s Hispanic/Latino nutrition awareness 

campaign. The campaign is designed to educate

Hispanics and their families, that food is a powerful

tool in diabetes control and to dispel the myth that

healthy eating means sacrificing taste and tradition.

Campaign materials include television, radio, and

print PSA's, posters, and a meal planner featuring

mouth-watering traditional Hispanic dishes.

“The Power to Control Diabetes Is in Your Hands”

is NDEP’s campaign targeted to older Americans.

The campaign educates older adults with diabetes

about the importance of self-monitoring blood glucose to control diabetes and promotes the availability of Medicare benefits for self-monitoring equipment and supplies. Launched with a video news

release in May 2001, Older Americans Month,

campaign materials include press kits, print ads,

brochures, posters, and community outreach and

health care practitioners kits.

“Move It!” is the call to action of the American

Indian Youth Campaign, which addresses the rising

prevalence of Type 2 diabetes in American Indian

young people. The campaign includes a series of 3

posters, a print ad, and a fact sheet and promotes 

the importance of physical activity to reduce risk 

of diabetes.

“Be Smart About Your Heart: Control the ABCS 

of Diabetes” creates awareness about the link

between diabetes and heart disease and promotes

comprehensive diabetes care to control blood glucose, blood pressure, and cholesterol—the ABCs of

diabetes. The “Be Smart” campaign was launched at

the annual meeting of the American Diabetes

Association in June.

Media Outreach 

In conjunction with these PSA campaigns, NDEP 

continued to conduct media outreach to obtain 

coverage about diabetes in the print and broadcast

media. Program messages were featured in a number

of national media outlets. Examples of health care 

professional journal articles NDEP placed were 

“The National Diabetes Education Program—

Changing the Way Diabetes Is Treated: Comprehensive

Diabetes Care,” editorial in Diabetes Care, April 2001

and “Current Treatment Goals for Type 2 Diabetes,”

in the Home Health Care Journal, June 2001. In

terms of consumer media, NDEP placed several articles about diabetes in HealthQuest magazine. NDEP

messages were also broadcast on the Russ Parr

Morning Radio Show and AARP Prime Time Radio.

NDEP Conference Participation 

Program spokespersons gave presentations and 

represented NDEP at several meetings in FY 2001.

Conferences included the American Dietetic

Association’s annual meeting in October 2000; the

Urban League of Nebraska’s “Lift Every Voice”

diabetes training workshop in January; the ADA

Postgraduate Course in January; the Diabetes 
DMICC ANNUAL REPORT 49 FY 2001

Health and Wellness Expo in March; the American

Association of Diabetes Educators Leadership

Conference in April and their annual meeting in

August; the CDC’s Diabetes Translation Conference 

in May; the Virginia Dietetic Association meeting in

August; the annual meeting of the ADA in June; and

the annual meeting of the American Academy of

Nurse Practitioners in July.

In addition, the NDEP continues to conduct workshops on the Diabetes Community Partnership Guide.

The workshops introduce participants to the Guide's

various community tools and activities, which are

designed to mobilize communities into action.

Eighteen workshops have been conducted to date

across the country; three of them in Spanish.

NDEP Speakers’ Kits 

In FY 2001, the NDEP developed a speaker’s kit, comprised of eight slide/script presentations that are

intended for use by partners at conferences and public events. The presentations include the same core

information about diabetes and the NDEP but they

have been tailored for various racial/ethnic audiences, people with diabetes, health care professionals, and health care purchasers and payers. In Fiscal

Year 2002, these presentations will be placed on the

NDEP web site for partners to access.

Diabetes at the Worksite 

NDEP’s Business and Managed Care Work Group 

has designed a web-based resource that employers,

human resource, and health professionals can use 

to assess the scope of the diabetes problem in their

workforces and to conduct diabetes education at the

worksite. This resource will be launched in Fiscal

Year 2002.

Diabetes in Children and Adolescents 

This work group is completing a set of resource

materials for health care professionals, parents, and

others concerned about diabetes in children and adolescents. Materials include fact sheets, an annotated

bibliography, and a resource directory. In addition,

a subcommittee of this work group is developing a

guide for “Managing Diabetes in the Schools” that

will be published and distributed in Fiscal Year 2002.

Health Care Professional Work Group Activities 

NDEP’s Health Care Provider work group provided

guidance for the Comprehensive Care Campaign 

and selecting the “ABCs of Diabetes” message. The

group is exploring various approaches to improve 

the quality of diabetes care; clinical practice tools

will be developed in 2002. The Pharmacy, Podiatry,

Optometry, and Dentistry (PPOD) work group is

developing a diabetes primer to expand PPOD 

professionals’ understanding of their role in care 

for people with diabetes beyond their own specialty

and to include education about the need for glycemic,

blood pressure, and cholesterol control for people

with diabetes.

During Fiscal Year 2002, NDEP will not only continue

to promote diabetes control but it also will take the

lead on translating and promoting the findings of the

recently completed Diabetes Prevention Program

(DPP) clinical trial. The DPP demonstrated that the

onset of diabetes could be prevented or delayed

among people at risk for the disease through modest

lifestyle changes such as 150 minutes of moderate

activity per week and losing 5 to 7 percent of one’s

body weight. This important prevention message will

add a new dimension to the NDEP and its goal of

“changing the way diabetes is treated.”

For more information about the National Diabetes

Education Program, please visit our web sites at

http://ndep.nih.gov and www.cdc.gov/team-ndep 

on the Internet.
MEETING SUMMARIES
DMICC ANNUAL REPORT 53 FY 2001

DIABETES AND AGING CONFERENCE

February 12-13, 2001

National Institutes of Health

Bethesda, Maryland

DAY 1

WELCOME 

– Allen Spiegel, Richard Hodes

The purpose of this conference was to bring together

researchers from the fields of gerontology and diabetology to examine issues surrounding the etiology,

impact and responses to diabetes in the aging population. Traditionally, researchers in these two disciplines have worked independently, though their

research interests often overlap. However, the rapid

growth of the population over sixty, taken together

with the increasing incidence of type 2 diabetes in

that population, seem to call for a more collaborative

effort. Therefore, we have invited laboratory and 

clinical researchers from both disciplines to tell us

about what they are learning and to help us to define

the next phase of needed research.

PRESENTATIONS

Overview of the Problem

The Evolution of the “Disease vs. Aging”

Controversy – Reubin Andres

Since gerontologists and diabetologists approach the

fact of diabetes in the elderly from different points of

view, it may be helpful to articulate the basic differences. In general, diabetologists regard the development of type 2 diabetes in the elderly as the result of

a disease process. Gerontologists are more inclined

to see the same development of diabetes as a fundamental consequence of aging. So the question is

whether the decline in glucose tolerance seen in 

elderly diabetics is a primary biological reaction to a

given stimulus or set of events, or whether there are

other characteristics about getting old that result in

such a decline.

This is not an easy question to address, much less

answer. Older people develop a large number of medical problems and take a wide array of medications.

Further, they are likely to have changes in diet and

activity patterns, as well as body composition when

compared to their earlier lives. Any of these variables, alone or in combination, have potential for

affecting the body’s ability to tolerate glucose. We

must then be very careful to be comparing apples

with apples as we approach the question.

This leads us to the issue of how we measure glucose

tolerance. Over time, our ability to measure glucose

tolerance has improved, but there is still a divergence

of measures used to diagnose the condition in clinical practice and in research. In order to draw meaningful conclusions from the data we collect we need

to have some common reference points. We need to

know if the same measure of glucose tolerance

means the same thing in twenty year olds, fifty year

olds and eighty year olds. We need to follow subjects

longitudinally if we hope to be able to develop standard reliable measures that may be used as reasonable predictors for diagnosis and management of

diabetes in the future. Combining the efforts of the

gerontologists and diabetologists can only benefit

this research.

MEETING SUMMARIES
DMICC ANNUAL REPORT 54 FY 2001

Scope and Impact of Diabetes in the Elderly 

– Maureen Harris

Data from a survey conducted in 2000 indicate that

there are 17 million diabetics in the US, half of which

are over 60 years of age. This means that almost 18%

of those aged 60 and older have diabetes. According

to the survey, nearly a third of all cases of diabetes

go undiagnosed. Rates of incidence are higher among

non-white populations than among whites.

The implications of this epidemic can be seen in the

increase in risk factors for macro and micro vascular

disease. Half the diabetics in the study had BBP

exceeding 140/90, or uncontrolled. More than half

also failed to meet the ADA goals for total cholesterol

of 200, and half failed to meet the goal of LDL lower

than 130. Additional impact from diabetes in those

over age 65 can be seen in the incidence of lower

extremity amputation, which increases with age. End

stage renal disease is another condition experienced

by elderly diabetics at a rate much higher 

than non-diabetics.

Another area where we see the impact of diabetes in

the elderly population is in physical disability. When

we look at rates of inability to manage ordinary

physical tasks such as walking, climbing stairs, and

housework, we see that diabetic women had twice

the rate of disability as women without diabetes. The

final place where the impact shows is in the significantly higher rate of mortality from all causes in diabetic men and women over age 65, when compared to

their non-diabetic counterparts.

Pathophysiology of Diabetes in Aging

– Josephine Egan (Chair)

In order to avoid developing diabetes the body must

maintain a balance between insulin secretion and

insulin sensitivity. In Type I diabetes there is an

absolute decline in insulin secretion. type 2 diabetes

occurs when insulin sensitivity declines for any reason and insulin secretion fails to increase to restore

the balance. type 2 diabetes is a progressive disease,

so control is an ongoing challenge, often requiring an

increase in numbers of medications, finally going to

insulin.

The progressive nature of the disease is the result of

a continuing Beta cell failure inside the islets. In various studies, researchers found that after the rodents

reached middle age, the islets no longer enlarged. The

number of Beta cells actually declines, and the

remaining Beta cells hypertrophy, so the islet size

does not decrease. At the same time, there is a

decline in the insulin messenger RNA in the islets

and a decline in the total pancreatic insulin. There is

also a decline in the sensing mechanism of the Beta

cells with age in rodents, so that the specific glucose

transporter, as well as glucokinase, the message and

the protein levels, both decline with age.

Factors Determining Glucose Tolerance in the

Elderly – Marilyn Ader

Without trying to account for the reason, we know

that insulin sensitivity decreases with aging and that

this decrease in insulin sensitivity is associated with

increased mortality from all causes. In spite of the

number of studies done to try to determine whether

the increase in insulin resistance in the elderly is a

natural consequence of aging, or a disease process,

controversy still exists. In fact, the body of research

produces conflicting data on the question.
DMICC ANNUAL REPORT 55 FY 2001

We see from the literature that investigators

approached the question in various ways, each focusing on different variables. They used animal and

human subjects, dynamic and steady state measures,

and longitudinal as well as cross-sectional data. They

focused on insulin sensitivity in both hepatic and

peripheral tissue, as well as insulin secretion under a

variety of conditions. They used both lean and obese

subjects, and they compared old vs. young, as well as

healthy elderly subjects vs. diabetic elderly subjects.

Though they were all trying to understand the etiology of increasing insulin resistance with age, they

were actually asking different questions. It is not

surprising then that the data give 

us conflicting conclusions.

Though there are differences in the literature, there

are also some common conclusions we can draw.

• Peripheral insulin resistance likely exists during

the sustained hyperinsulinemic conditions of the

glucose CLAMP.

• Under dynamic conditions of the OGTT or the

IVGTT, the magnitude of the insulin resistance 

may be greater.

• Hepatic resistance, impaired suppression of 

glucose production, may be evident in the dynamic

condition.

• Visceral adiposity does increase with age, but 

there have not yet been enough studies done that

have corrected the insulin sensitivity for central

fat. We need to know more about age-associated

changes in insulin sensitivity associated with 

visceral adiposity.

• We need to pay close attention to how secretory

function is measured. All measures are not equal.

We get different results for diagnosis and incidence

depending on what measure we use.

• Secretory function needs to be assessed in terms 

of rising insulin resistance with age.

Basic Mechanisms of Insulin Resistance 

– Nir Barzilai

We are looking for a cause and effect relationship

between aging and insulin resistance. We know that

the insulin resistance syndrome in the elderly is

associated with obesity, disease, and mortality from

all causes. In the rodent model we see that visceral

fat appears to pose a much greater risk for morbidity

than does the total fat in the body mass index.

We are looking at the hypothesis that longevity is

limited by lipotoxicity. Rodents in the wild are lean,

extremely active, and survive on far fewer calories

than do ad libinum fed animals in the laboratory.

This kind of caloric thrift gives the genes the greatest

chance of being reproduced. If the animal eats more

calories than it needs for survival, and begins to

accumulate excess fat, the metabolic system is

required to compensate for the excess demand. It is

important to note here that the greatest increase in

risk of insulin resistance occurs with an increased

distribution of fat to the visceral area.

We see in obese rodents that when we remove 

the visceral fat, their insulin sensitivity improves

significantly, even when less than 15% of total fat is

removed. Since it is possible for a lean looking 

individual to have a high concentration of body fat 

in the abdominal region, it is important that we

understand the processes at work in both the

increased risk for insulin resistance as it relates to

visceral fat, and in the decreased risk generally 

seen in caloric restriction.
DMICC ANNUAL REPORT 56 FY 2001

Insulin Secretory Deficits in the Elderly with 

and without Diabetes – Graydon Meneilly

In spite of the number of studies done in this field,

there still exists a large amount of controversy

regarding the cause and impact of insulin secretory

deficits in the elderly. When life style factors, such as

diet, activity level, and body composition are adjusted for in community dwelling older subjects by multiple regression analysis, the effects of aging per se

in the OGTT is very small. One area of concern is the

European study that showed that there is a decrease

in insulin clearance in older individuals. This would

mean that the ability to maintain physiological levels

of glucose in the aging may be due to a reduced rate

of insulin clearance, not to an appropriate rate of

insulin production. There also seem to be changes in

more subtle measures in the elderly involving the

burst mass and regularity of insulin pulses, both in

rapid and ultradian insulin responses, under both

fasting and hyperglycemic conditions.

Lean older people with diabetes tend to have a profound impairment in glucose induced insulin secretion when compared to age matched non-diabetic

controls. Obese older people with type 2 diabetes

have an absence of first phase insulin secretion, but

they have a relatively modest impairment in second

phase insulin secretion when compared to age

matched non-diabetic controls. All older people with

type 2 diabetes have marked defects in insulin secretion. The magnitude of the secretory defect is greater

in lean patients than it is in obese patients, but all

older patients have a defect in Beta cell secretion of

insulin for various reasons. With GLP, and potentially

with many other interventions that we have at our

disposal, we can partly or completely reverse some of

the defects in insulin secretion that occur in older

people in association with diabetes.

Basic Defects in Insulin Secretion and the Beta

Cell with Age – Peter Butler

The traditional belief has been that humans do not

grow new islets over time, yet we have autopsy evidence that new islet production occurs even in those

over 90 years of age. There is also speculation that

Beta cell mass inevitably decreases with aging, but

this has not been demonstrated. However, we still see

a typical decline insulin sensitivity for various reasons in humans as they age. Some of this can be

attributed to possible genetic defects at the level of

the islet. We know that there is a minimum Beta cell

mass needed to avoid the development of diabetes.

We are beginning to learn what happens inside the

Beta cell and the islet that may help to explain Beta

cell death and the consequent decline in insulin producing capacity.

There are striking similarities between the decline 

of Beta cells seen in type 2 diabetes and the decline

of brain cells seen in Alzheimer’s. There is consistent

evidence in both diabetes and Alzheimer’s research 

to indicate that amyloid material exists inside the

cells prior to their deaths. The protein is found only

in pathological circumstances. Cell death in both 

diseases is highly correlated with small intra-cellular

aggregates of amyloid. In both diseases there seem to

be deficits of chaperone proteins necessary to protect

the secretory protein from aggregating as it moves

within the cell. The processes of cell destruction in

both type 2 diabetes and Alzheimer’s are so similar

that it is quite possible that if we find the cause for

one, we will also find the cause for the other.
DMICC ANNUAL REPORT 57 FY 2001

Molecular Events of Insulin Signal Transduction 

– Mark Lane (Chair)

The Possible Role of Insulin Signaling in Aging

and the Retardation of Aging and Age-related

Disease by Caloric Restriction – Mark Lane

There is essentially no literature about molecular

events in the development of diabetes in aging. We

have a lot of questions, but few answers about the

role of insulin signaling in caloric restriction and its

relationship to aging and age related disease. We

know that there are many genes and processes that

are responsive to insulin within the cell. We also

know that ad libidum fed animals die earlier and

have higher rates of morbidity than do those on

caloric restriction. So there is a high correlation

between caloric restriction and extended lifespan.

The insulin pathway is a major sensor and transducer of the energetic status of the animal, and we may

speculate that this pathway plays a significant role

in the benefits seen in caloric restriction.

Caloric restriction reduces “energy” intake and may

extend lifespan by altering carbohydrate metabolism

or stress resistance. When animals can find more

than adequate food, more of their energy can be

devoted to growth, development, and reproduction.

When food is scarce, a higher proportion of energy

needs to be devoted to repair, maintenance and survival. In caloric restriction, the energy expenditure

ratio changes to emphasize maintenance and 

survival, making the organism more resistant to

stress. So it appears that stress response is greatly

enhanced in caloric restriction and may be 

significant in life extension.

The DAF-2 Pathway of the Nematode

Caenorhabditis elegans as a Homolog of the

Insulin Signaling Pathway in Mammals:

Similarities and Differences – Thomas Johnson

C. elegans is an excellent organism for the study of

aging. It has only 1000 cells and is thoroughly

mapped. In addition, it is optically transparent,

enabling researchers to tag particular proteins and

track them in the animal. C. elegans offers several

classes of gerontogenes for study. The generation

length is only three days. When the animals are fed

ad libidum, they multiply from one egg to 100,000

worms in a week.

When food supplies are exhausted, the animal form

an alternative form called “dauer larvae”, a migratory

stage during which metabolism continues. When food

is inadequate, this condition is sensed by a series of

genes, whose basic output is the formation of dauers.

These DAF (dauer formation defective) genes are

involved in a coordinated pathway that starts with 

a putative insulin receptor, such as DAF-2 that has

very high homology to the insulin IGF-1 receptor in

mammals. Proteins in the insulin signaling pathways

in c. elegans are homologous to a great degree with

identifiable proteins filling similar functional roles in

mammals. There is a signal transduction cascade

driven by kinase action whose ultimate output is the

DAF-16 gene, which is closely associated with stress

resistance and extended lifespan in the worm.

While the c. elegans model is very useful helping us

understand the interaction of the genes in this pathway, the output of these different pathways is quite

different. Worms respond to the output by forming

dauers, while mammals probably experience some

metabolic shift in response to the absence of food. In

worms, there is an obvious trade off between dauer

formation and reproduction. In mammals, the output

from this pathway is perhaps more likely to be

expressed in terms of the animal’s ability to resist

stress, which then has implications for morbidity

and lifespan.
DMICC ANNUAL REPORT 58 FY 2001

The Role of IRS Proteins in Growth and

Metabolism – Morris White

Insulin action has an enormous influence on 

mammalian physiology beyond what we ordinarily

think of as glucose metabolism measured by glucose

uptake in fat and muscle. In mammalian systems up

to 80 or 90% of insulin signals are mediated through

IRS (insulin receptor signal) proteins. We have identified a range of IRS proteins and other receptors and

understand some of their roles in insulin signaling

and response.

The insulin signaling pathway involves a large number of proteins that all need to function in a coordinated way in order to achieve optimum gluco-regulation. These proteins perform the additional function

of coordinating the physiology and growth in brain,

liver, ovary, adipose and muscle tissues. We need,

therefore, to look at the impact of this pathway

beyond the disease processes we typically think of 

in association with diabetes. We need to examine 

the specific ways that age related alterations in the

insulin signaling pathway influence the development

of a wide range of age associated diseases and 

related disability.

Insulin Signaling and Action in Skeletal Muscle:

Effects of Age and Caloric Restriction 

– Gregory Cartee

Muscle is important for disposing of blood glucose in

response to insulin. Muscle insulin resistance is an

early defect in type 2 diabetes, and muscle function

is highly dependent on metabolism. Insulin signaling

is therefore, very important to muscle function. In

order for insulin to enter the muscle cell, a GLUT 4

transporter must move to the cell surface. We set out

to describe the calorie restriction effect on glucose

transport in animals at various ages in both calorierestricted groups and ad libidum fed groups. We used

isolated muscle cell preparations for our analyses.

We looked at both long and short- term calorie

restriction and found that there were significant

improvements in glucose transport in both cases.

Though there are declines in GLUT 4 abundance with

age, we see significantly more cell surface insulin in

elderly CR animals than in the elderly ad libidum fed

animals at the same insulin levels. We have reason 

to believe then, that age related insulin resistance in

skeletal muscle likely involves altered insulin 

signaling.

Old animals do respond to single session and chronic

exercise with a substantial increase in insulin stimulated glucose transport. Skeletal muscle remains

responsive to calorie restriction and to exercise

induced improvements and insulin sensitivity during

old age. The underlying mechanisms for improved

insulin signaling and action with calorie restriction

and exercise appear to be different, yet both likely

involve amplified insulin signaling.

Prevention and Treatment 

– James Meigs (Chair)

Carbohydrate Metabolism in Dietary 

Restriction and Aging – Mark Lane

We are testing the hypothesis that caloric restriction

will extend life span, prevent or delay onset of age

related diseases, and slow the rate of aging in rhesus

monkeys. The work is being done at a three labs,

using a range of diets, feeding protocols and ages of

the animals at the initiation of restriction. In calorie

restricted animals we find a decline in total body fat,

body weight, and abdominal fat. CR animals have a

significant reduction in the peak level of glucose.

This goes up with age. Glucose tolerance goes down

with age.
DMICC ANNUAL REPORT 59 FY 2001

When we surveyed the medical records of the monkeys for chronic disease and mortality in both the

calorie restricted populations and the controls, preliminary data indicate that calorie-restricted animals

have only half the deaths due to chronic disease seen

in the control animals. Data from both rodents and

monkeys indicate that caloric restriction is an effective means for improving glucose tolerance and

increasing insulin sensitivity. The effects of calorie

restriction and gluco-regulation can occur after only

a short time on restriction and may not be entirely

dependent on changes in body composition.

Glycemia and Risk for Cardiovascular Disease 

– James Meigs

We used the Framingham Heart Study to look at 

the relationship between glycemia and risk for CVD.

We looked at data from both the original cohort

study and the offspring study and asked the 

following questions:

1. What is the prevalence of diabetes with age 

using various diagnostic criteria?

2. What is risk for CVD associated with hyperglycemia among older persons? What is the 

association between hyperglycemia and CVD?

3. What is the risk for CVD associated fasting and 

2-hour hyperglycemia measures according to 

different thresholds?

Though the data are limited in a number of ways,

we are able to draw some conclusions.

• Diabetes is common, even among the very old subjects. If that is true, and people with diabetes tend

to die young, then new cases are continually developing, even in the very old.

• Isolated post challenge hyperglycemia is very 

common in older people, so a fasting plasma glucose screening would fail to identify many in this

population at increased risk for CVD.

• Hyperglycemia is an independent CVD risk factor

in older people.

• Hypertension is an important modifiable CVD 

risk factor in the elderly.

• Hypertension is a highly prevalent concomitant 

of diabetes.

• Post- challenge hyperglycemia is an independent

risk factor for CVD, especially in older subjects.

In thinking about interventions to reduce CVD,

it may be worth focusing on post- challenge hyperglycemia is an attractive target.

The Pathway from Diabetes to Disability:

Optimal Targets for Intervention in the Elderly 

– Helen Hazuda

This talk presents a series of statistical analyses

using data from the San Antonio Longitudinal Study

on Aging (SALSA). The study contains a nested, case

controlled study that follows incidence of functional

decline in subjects with and without diabetes. The

aim of the study is to better understand the pathways between disease and disability in order to identify optimal targets for intervention. We are using a

basic model identifying the stages leading to disablement, which include pathology, impairment, functional limitation, and disability. Data was collected at

three different times over 18 months, looking for

both trends and causes of disablement.
DMICC ANNUAL REPORT 60 FY 2001

As different variables are included, the model

becomes very complex. We tested the various hypothesized pathways by first adjusting for contextual

variables of age, gender, ethnic group, education, and

household income. We then begin to see involvements

that we did not expect, such as the significant decline

in musculo-skeletal function in the presence of diabetes. Although the percent of disability found to 

be due to diabetes was modest when compared to

that attributable to context, even small percentages

have a large public health impact in a population of

8.3 million diabetics. It is therefore important to be

able to identify and understand the modifiable 

variables so that we can begin to develop effective

interventions.

Pharmacological Treatment of Diabetes in

Elderly People: Challenges and Opportunities

– Jeffery Halter

Establishing appropriate, effective pharmacological

treatment for elderly people with diabetes is a challenge because we don’t know who has this condition,

why they have it, or what we are trying to accomplish for them. We don’t have uniform protocols or

measures for diagnosis. Our main concerns are the

range and rate of development of complications seen

in elderly people with type 2 diabetes, as well as the

increase in risk factors for other diseases. Many 

elderly people with diabetes have co-existing health

problems, and are on several medications, some 

with side effects, so controlling hyperglycemia and

establishing clear treatment priorities becomes

extremely complex.

The clinical and research picture is further complicated by the varying perceptions of this population

held by practitioners. Diabetologists tend to view

these people as likely to be frail, dependent, and poor

candidates for aggressive intervention, while the

image held by most gerontologists is that most older

people with diabetes are quite functional, independent, interested in their health and pursuing their

interests in life. Clearly, this difference in perception

leads to different levels of aggression in treatment,

so we need to develop criteria to help clinicians make

decisions about appropriate types and degrees of

treatment in response to the actual overall condition

of the patient.

type 2 diabetes is hard to treat over time. It is a progressive disease and requires an increasing number

and dose of medications as the patients age. We generally fail to achieve ADA goals in screening for frequently seen complications in this population. For

some common circumstances, we have thinly

researched guidelines or none at all, as in the case of

post-prandial hyperglycemia. With improved screening and diagnosis, we could much more adequately

address the needs of the elderly who have diabetes

than we now do.

Clearly, the treatment goals appropriate for an independent, active older person with diabetes need to be

different from those for a patient in a skilled nursing

setting. We have a variety of pharmacological treatment options including the standard collection of

sulfonylureas, a growing number of specifically targeted insulins, as well as the newer combination

therapies. We need to work harder to establish and

promote appropriate treatment goals for all elderly

persons with diabetes. We should not be excluding

people from treatment arbitrarily because of age.

Clinical Overview of Diabetes and Aging 

– Robert Schwartz

This is a personal view of the current state of diabetes and aging. We can see that the population over

age 65 is increasing rapidly as is the incidence of

type 2 diabetes in that population. This increase carries with it a substantial burden of medical complications, cost, and disability. At present, type 2 diabetes in the elderly is seriously under diagnosed, so

it is also under treated. We do an inadequate job of

employing the tools we have available to screen for

and diagnose the disease. We lack a commonly

accepted protocol for diagnosis and treatment in 

the elderly population.
DMICC ANNUAL REPORT 61 FY 2001

Treatment of diabetes in the elderly is complicated

because of the changes in physiology seen in aging,

the increase in risk factors for other diseases, the

frequent occurrence of other medical conditions, and

multiple medications. type 2 diabetes is a progressive disease, making it very difficult to treat over the

long term. Available treatments typically have either

high cost or considerable risk of hypoglycemia associated with them, and they are often inadequate to

control the condition in the elderly. We do see promise in the new drug, Metformin.

Finally, appropriate treatment is frustrated by the

belief on the part of many clinicians that individuals

in this population are frail and have very limited life

expectancies, so it is inappropriate to pursue aggressive treatment of their diabetes. In fact, at age 65

many women can expect to live for 19 years and

many men can expect to live for 15 years. Undertreatment for diabetes and associated conditions

may contribute substantially to portion of the

remaining lifespan that will be spent in a dependent

state. The public health consequences of untimely

and inadequate care of the elderly with diabetes 

will be enormous unless we can work together to

improve both the timeliness of intervention and the

level of that care.

DAY 2

WORK GROUPS

Conference participants divided into three topic

groups to design and compile lists of questions and

topics that describe the most pressing research

needs in the emerging field of diabetes and aging.

Each group then presented its work to the full conference. The work group reports follow.

Patho-physiology Work Group Report

1. What is the role of body fat distribution in agerelated peripheral and hepatic insulin action 

and glucose intolerance?

2. What is the role of insulin independent processes

in age-related glucose intolerance?

3. What are the metabolic consequences of fat products such as free fatty acids and fat derived peptides, and how do they change with aging?

4. What are the metabolic consequences of age-related changes in glucose levels?

5. What are the mechanisms contributing to postprandial hyperglycemia, that are seen as a function

of age?

6. Does Beta cell function change with age, and what

are the mechanisms of change? 

7. How does Beta cell mass change with age, and

what are the mechanisms? 

8. Can adverse changes in function and mass be ameliorated?

9. Should we establish a cooperative group in order

to obtain human autopsy tissues such as pancreas,

liver, fat, muscle?
DMICC ANNUAL REPORT 62 FY 2001

10. Is there a mechanism whereby we in the type 2

DM field can obtain human islet cells for study?

11. What are the mechanisms underlying the change

in the relationship between insulin secretion and

insulin action with age? Can they be reversed?

12. Given the comparable pathology seen in

Alzheimer’s disease and type 2 diabetes, are the

mechanisms leading to the neural and Beta cell

dysfunction related?

Insulin Signal Transduction Group Report

General considerations

1. In addition to diabetes, insulin and insulin action

are likely to be involved in many age associated

diseases and pathologies.

2. It is important to more specifically define the role

of insulin action on various age associated

pathologies including syndrome x, Alzheimer’s, etc.

3. Alzheimer’s literature is beginning to discuss

Alzheimer’s as “diabetes of the brain”.

Recommendations

1. We need to describe changes in insulin signaling

that occur with aging in rodent models first. This

is not necessarily looked upon favorably by study

sections, and review boards, etc. Therefore it may

require different funding mechanisms than usual.

2. Once the descriptive studies are done, the next

step is to utilize those findings to develop targets

for enhancing insulin action in peripheral tissues

of older and /or diabetic individuals.

3. We need to define the role of tissue specific

changes (other than those we typically think of as

being involved in diabetes) in insulin action with

age, independent of those changes involved solely

in carbohydrate metabolism.

4. We need to understand the impact of aging and

hyperglycemia, both independently and together 

on Beta cell function. Then we need to develop 

targets for improving Beta cell function in older 

individuals.

Models and Model Systems

1. We need to identify genes and mutations in

humans associated with insulin resistance in

aging, looking at micro-array and classic 

epidemiological studies.

2. Once those genes are identified, they could then be

used in rodent models to do more mechanistic

studies, either by inserting the human gene, or by

altering the expression of a rodent homology to

determine the effects or significance of that gene.

3. Non-human primates offer some advantages for

this work because most of the variables can be

controlled in a laboratory setting.

4. More functional (physiological/ biochemical) studies in c. elegans are needed to relate genetic studies in the worms to mammalian aging and disease.

Interventions

Both calorie restriction and exercise have been

shown to improve insulin action, perhaps even in

older individuals, and should be utilized in studies 

of aging and insulin action.
DMICC ANNUAL REPORT 63 FY 2001

Miscellaneous

1. Is it better in aging to be more or less insulin 

sensitive?

2. Are there separate contributions of insulin level 

vs. insulin sensitivity to age-associated disease? 

Is it only insulin sensitivity, or is there some worth

in considering the impact of hyper-insulinemia or

insulin level in the blood itself?

3. If diabetes is a disease of signal transduction,

maybe glucose has been over-emphasized in its

importance. Should we consider insulin and

insulin action in greater detail in diabetes as 

well as other diseases of aging?

4. We need to better understand the role of signal

transduction mechanisms in relation to regulation

of insulin secretion.

5. What is the role of nutrient sensing pathways in 

a variety of age related changes and diseases?

Prevention and Treatment Work Group Report

How do we define type 2 diabetes in the elderly?

Research Questions

1. Are there fast vs. slow progressors?

2. Should OGTT screening be performed?

3. Can a combination of fasting plasma glucose 

and HbA1c be used to identify at risk subjects?

4. Is fasting insulin a useful marker of disease?

Goldberg’s paper emphatically said no for 

older people.

5. Should, and how should, insulin assays be 

standardized?

6. Are there existing population data bases that 

can be exploited to advance knowledge?

7. What new data should be collected?

What causes the complications of diabetes

in the elderly?

• Hyperglycemia is common.

• Coexistent risk factors are common.

• Treating hyper-lipidemia and hypertension is 

beneficial.

Research Questions

1. What is the significance of isolated post-challenge

hyperglycemia as a risk factor? Is this true 

for hyperglycemia that happens after a meal?

2. What is the marginal benefit of controlling hyperglycemia beyond control of lipids and BP?

3. Are lifestyle interventions (exercise and weight

loss) sage and effective in the elderly?

4. Is the observational data sufficiently complete 

that RCTs can now be recommended?

How should we prevent /treat diabetes in the elderly?

• Goals for treatment overall may not be applicable

in the elderly. One size does not fit all.

• We know a lot about how to prevent complications.

• Evidence-based recommendations are not being

applied in clinical practice.
DMICC ANNUAL REPORT 64 FY 2001

Research Questions

1. What are appropriate goals for glycemic control 

in sub-groups of elderly aimed at preventing

death or increasing function?

2. When should treatment be started, with prevention, with onset of symptoms, or with the appearance of complications?

3. What are appropriate goals of treatment?

Prevention of mortality? Prevention of complications? Quality of overall life?

4. Poly-pharmacy is a problem with respect to cost,

adherence, and side effects.

5. How can we address this? 

6. Can we package drugs together to minimize 

the number of pills?

7. How can evidence be translated into practice? 

8. What types of studies will inform better evidence-based care? We need to fund research to

study care in managed care settings.

9. How can modern informatics/technology be 

used to enhance care?

10. How can we develop the clinical, geneological,

and epidemiological data to better tailor treatment to individual differences in older patients?
DMICC ANNUAL REPORT 65 FY 2001

SPEAKERS

Dr. Marilyn Ader, PhD

USC School of Medicine

Physiology and Biophysics

1333 San Pablo Street, MMR 624

Los Angeles, CA 90089

Phone: (323) 442-1921

Fax: (323) 442-1918

E-mail: ader@hsc.usc.edu

Reubin Andres, MD

Laboratory of Clinical Investigation

Gerontology Research Center

National Institute on Aging

Building GRC, Room 2B13

5600 Nathan Shock Drive

Baltimore, MD 21224

Phone: (410) 558-8193

Fax: (410) 558-8113

Email: andresr@grc.nia.nih.gov

Nir Barzilai, MD

Albert Einstein College of Medicine

Diabetes Research and Training Center

1300 Morris Park Ave

Belfer 701

Bronx NY 10461

Phone: (718) 430-3144

Fax: (718) 430-8557

Email: barzilai@aecom.yu.edu

Robin Boineau, MD

National Heart, Lung, and Blood Institute

Medical Officer, Cardiologist

6701 Rockledge Drive, MSC 7936

Room 8142

Bethesda, MD 20892-7936

Phone: (301) 435-0707

Email: boineaur@nhlbi.nih.gov

Edward J. Boyko, MD, MPH

Professor of Medicine

University of Washington

Director, Seattle ERIC

1660 S. Columbian Way (S-152E)

Seattle, WA 98108 USA

Phone: (206) 764-2830

Fax: (206) 764-2849

Email: eboyko@u.washington.edu

Peter Butler, MD

Professor of Medicine

Chief, Endocrinology and Diabetes

University of Southern California

Keck School of Medicine

1333 San Pablo Street, BMT-B11

Los Angeles, CA 90089

Phone: (323) 442-2804

Fax: (323) 442-2809

Email: pbutler@hsc.usc.edu

Gregory D. Cartee, PhD

Department of Kinesiology

University of Wisconsin

2000 Observatory Drive

Madison, WI 53706

Phone: (608) 262-7715

Phone2: (608) 262-7944

Fax: (608) 263-4242

Email: cartee@education.wisc.edu

Chhunda Dutta, PhD

Director

Musculoskeletal Research and Nutrition 

Metabolism and Gastrointestinal 

Research, Geriatrics Program

National Institute on Aging

Gateway Building, Suite 3E327

7201 Wisconsin Avenue

Bethesda, MD 20814

Phone: (301) 435-3048

Fax: (301) 402-1784

Email: duttac@exmur.nia.nih.gov
DMICC ANNUAL REPORT 66 FY 2001

Sanford Garfield, PhD

National Institute of Diabetes and Digestive 

and Kidney Diseases

6707 Democracy Blvd,

Room 685, MSC-5460

Bethesda, MD 20892-5460

Phone: (301) 594-8803

Fax: (301) 480-3503

Email: garfields@extra.niddk.nih.gov

Edward Gregg, PhD

Epidemiologist

National Center for Chronic Disease 

Prevention and Health Promotion

Centers for Disease Control & Prevention 

KOGR Building, Mail Stop K68

Atlanta, Georgia 30341

Phone: (770) 488-1273

Fax: (770) 488-1148

Email: edg7@cdc.gov

Jeffrey B. Halter, MD

Geriatrics Center

University of Michigan

1500 E Med Center Drive, 1111 CCGCB

Ann Arbor, MI 48109

Phone: (734) 763-4002

Fax: (734) 763-2064

Email: jhalter@umich.edu

Maureen I. Harris, PhD, MPH

Director, National Diabetes Data Group

National Institute of Diabetes and Digestive 

and Kidney Diseases

6707 Democracy Blvd,

Room 695, MSC-5460

Bethesda, MD 20892-5460

Phone: (301) 594-8801

Fax: (301) 480-3503

Email: mh63q@nih.gov

Helen P. Hazuda, PhD

Professor of Medicine

Department of Medicine 

Division of Clinical Epidemiology

University of Texas Health Science Center

Mail Code 7873

7703 Floyd Curl Drive

San Antonio, TX 78229-3900

Phone: (210) 567-6678

Fax: (210) 567-1990

Email: hazuda@uthscsa.edu

Thomas E. Johnson, PhD

Professor of Molecular Behavioral Genetics

Institute for Behavioral Genetics, Box 447

University of Colorado at Boulder

Boulder, CO 80309

Phone: (303) 492-0279 

Fax: (303) 492-8063

Email: johnsont@colorado.edu

Mark A. Lane, PhD

Chief, Nutritional and Molecular Physiology Unit

Laboratory of Neurosciences

National Institute on Aging

5600 Nathan Shock Drive

Baltimore, MD 21224

Phone: (410) 558-8481

Fax: (410) 558-8323

Email: mlane@vms.grc.nia.nih.gov

Mimi Lising, MPH

Director

Special Populations Outreach Program

National Institute of Diabetes and Digestive 

and Kidney Diseases

31 Center Drive 

Bldg. 31, Room 9A04

Bethesda, MD 20892-2560

Phone: (301) 435-8116

Fax: (301) 496-7422

Email: mimi_lising@nih.gov
DMICC ANNUAL REPORT 67 FY 2001

James B. Meigs, MD, MPH

Assistant Professor of Medicine, HMS

General Internal Medicine Unit

Massachusetts General Hospital

50 Staniford St. 9th floor

Boston MA 02114

Phone: (617) 724-3203

Fax: (617) 724-3544

Email: jmeigs@partners.org

Graydon Meneilly, MD

Vancouver Hospital and Health Science Center

UBC Site, RmS 169

2211 Westbrook Mall

Vancouver BC V6T 2B5

Canada

Phone: (604) 822-0748

Fax: (604) 822-7897

Email: meneilly@interchange.ubc.ca

Marian A. Parrott, MD, MPH

National Vice President, Clinical Affairs

American Diabetes Association

1701 Beauregard Street

Alexandria, VA 22311

Phone: (703) 299-5533

Fax: (703) 549-1500

Email: mparrott@diabetes.org

Judith A. Salerno, MD, MS

Veterans Health Administration

US Deptartment of Veterans Affairs

810 Vermont Avenue, NW (114)

Washington, DC 20420

Phone: (202) 273-8540

Fax: (202) 273-9131

Email: judith.salerno@mail.va.gov

Robert S. Schwartz, MD

Head, Division of Geriatric Medicine

Division of Geriatric Medicine

University of Colorado Health Sciences Center

4200 E. Ninth Ave., Box B-179

Denver, CO 80262

Phone: (303) 315-8668

Fax: (303) 315-8666

Email: robert.schwartz@uchsc.edu

Lorraine Valdez, BSN, MPA, CDE

Nurse Consultant

National Diabetes Program

Indian Health Services

5300 Homestead Road NE

Albuquerque, NM 87110

Phone: (505) 248-4182

Fax: (505) 248-4188

Email: s.lorraine.Valdez@mail.his.gov

Huber Warner, MD

National Institute on Aging

Gateway Building, Room 2C231

7201 Wisconsin Avenue

Bethesda, MD 20814

Phone: (301) 496-6402

Fax: (301) 402-0010

Email: warnerh@gw.nia.nih.gov

Morris F. White, PhD

Joslin Diabetes Center

1 Joslin Place, Room 620

Boston MA 02215

Phone: (617) 732-2578

Fax: (617) 732-2593

Email: Lauren.Kelly@joslin.harvard.edu
DMICC ANNUAL REPORT 68 FY 2001

OTHER PARTICIPANTS

Michel Bernier, PhD

Laboratory of Clinical Investigation

National Institute on Aging

National Institutes of Health

5600 Nathan Shock Drive, Box 23

Baltimore, MD 21224-2780

Fax: (410) 558-8381

Phone: (410) 558-8199

E-mail: bernierm@vax.grc.nia.nih.gov

Josephine Egan, MD

Acting Chief, Diabetes Section

Laboratory of Clinical Investigation

Gerontology Research Center

National Institute on Aging

5600 Nathan Shock Drive

Baltimore, MD 21224

Phone: (410) 558-8414

Fax: (410) 558-8381

Email: eganj@vax.grc.nia.nih.gov

Tamara Harris, MD

National Institute on Aging

Gateway Building, Room 3C309

7201 Wisconsin Avenue

Bethesda, MD 20814

Phone: (301) 496-1178

Fax: (301) 496-4006

Email: harrista@nia.nih.gov

Leonard M. Pogach, MD

Veterans Affairs Medical Center

385 Tremont Avenue

East Orange, NJ 07019

Phone: (201) 676-1000

Fax: (201) 677-4408

Email: leonard.pogach@med.va.gov
DMICC ANNUAL REPORT 69 FY 2001

DIABETES MELLITUS INTERAGENCY

COORDINATING COMMITTEE MEETING 

ON DIABETES AND AGING

February 12-13, 2001

National Institutes of Health

Bethesda, Maryland

WELCOME

Program Activities in Diabetes and Aging

– Sanford Garfield (Chair)

This afternoon we will hear presentations from

DMICC agencies telling us what they are working 

on and what opportunities are available in their

organizations for further research.

PROGRAM ACTIVITIES AND 

RESEARCH OPPORTUNITIES

A summary of the presentations by representatives

from DMICC member organizations. It gives a brief

description of activities being carried on in each, as

well as resources available in the organization for

further research. It details available databases, populations, funding sources, etc. mentioned by the presenters. Contacts for each organization are included.

Centers for Disease Control

Program Activities

• Surveillance and epidemiology of incidence of 

disease, and its causes, treatments, complications

and resulting disability.

• Translation research- study of whether, how, and to

what degree of success efficacious interventions are

being implemented at the clinical level.

• Implementation of research findings- Serve as

clearinghouse for wide range of research so that it

is made available and can be put into practice at

the clinical level.

Current Study

Translating Research Into Action in Diabetesa multi-center of diabetes treatment in managed 

care settings.
Indian Health Service

Characteristics of Native American Populations

• Strong cultural identity

• High rate of poverty and underinsurance

• Generally poor health with high rates of 

alcoholism

• High incidence of diabetes in young and old

• Existing diabetes care, prevention, and education

programs emphasize service to the elderly.

Research needs

HIS needs data of all kinds related to diabetes 

in these communities, especially in the elder 

population.

Veterans Health Administration

Program Description

• Covers 9.3 million people over age 65,

primarily male

• Largest integrated health care program in the country, comprising 22 regional networks

• 13% of $21 billion yearly budget spent on 

geriatrics

• All patients linked to primary care practitioner

• Performance measures in place for management 

of patient care

Research Opportunities

Data mining of completely computerized patient

records, as well as information on income and 

demographics.

National Diabetes Education Program 

Program Description

• Public and private partners working together 

to reduce the pain suffering and death due to 

diabetes.

• Trying to reach diabetics and their families as 

well as those who treat and pay for care

• Want to increase awareness of diabetes to improve

diagnosis, treatment, lifestyle and testing

Current Activity

“Control Your Diabetes for Life” Campaign, aimed at

promoting the message that diabetes is treatable,

and that successful treatment is dependent on the

involvement of patients in their own care.

DMICC ANNUAL REPORT 70 FY 2001
American Diabetes Association

Program Description

Mission is to prevent and cure diabetes and improve

the lives of people affected by diabetes through

• Supporting research - especially for novel

approaches, new investigators, and supplemental

studies

• Providing information to professionals: 

professional programs, journals, clinical 

practice recommendations, and recognition 

and accreditation programs for physicians 

and organizations.

• consumers – website, including all journals and

clinical recommendations, call center, publications,

and referrals to recognized programs. Outreach

focus on children, African Americans, Hispanic

Americans, and Native Americans.

• Advocacy- to increase funding for diabetes

research, improve insurance coverage, end 

discrimination in schools and in work places.

Opportunities

At present trying to expand limited activity 

on diabetes in aging. Looking for volunteers 

to serve on a professional council on aging.

National Institute on Aging

Biology of Aging Program funds research in

• Non-enzymatic glycation

• Caloric restriction

• Insulin signaling

Research Opportunities

New animal model – Dwarf mice, extremely 

long lived, having defective genes involved with 

pituitary development. Lower blood glucose, higher

insulin sensitivity, lower insulin levels than other

laboratory animals.

Geriatrics Program funds research on

• Body composition changes

• Metabolic changes

• Caloric restriction

Research Opportunities

Currently waiting to award funds for study of 

caloric restriction in non-obese elderly people.

DMICC ANNUAL REPORT 71 FY 2001
DMICC ANNUAL REPORT 72 FY 2001

National Institute of Diabetes and 

Digestive and Kidney Diseases

Program Activities 

Supports research across divisions that contribute to

understanding of diabetes and the aging process

Division of Diabetes and 

Endocrinology supports

• Diabetes Prevention Program: Multi-center randomized controlled trial to determine whether interventions can be designed that can prevent the development and onset of type 2 diabetes

• Investigator-initiated grants

Division of Digestive Diseases and 

Nutrition supports

• Look AHEAD study following the consequences of

intentional weight loss in population of individuals

with type 2 diabetes over the course of the aging

process. Recruitment of 45-75 yrs olds, to begin in

June 2001.

Division of Kidney, Urologic and 

Hematologic Diseases supports

US Renal Data System in developing the database

that follows population with endstage renal disease.

National Heart, Lung and Blood Institute

Program Activities 

• Honolulu Heart Study – observational study 

started in 1965, including over 8000 Japanese

American men. Looking at stroke in men age 45 

to 65 at study entry.

• Strong Heart Study – study of three geographically

diverse groups of 4500 Native Americans age 45-74.

Currently in year 12. Plan to study 3600 people

from 120 families for genetic linkage analyses.

• Cardiovascular Health Study – four US 

communities, aged 65 and older.

• Framingham Heart Study

• Action to Control Cardiovascular Risk in Diabetes -

multi-center trial to assess rate of major CVD

events that can be reduced by intensive control of

blood sugar. New study intended to have 10,000

participants. Will compare blood pressure control

and diabetes control for individuals aged 45 and

older in Native Americans, 55 and older in Asian

and Hispanics, and 65 and older in Caucasian and

African Americans. Expect 60% of study population

will be 65 and older.

Research Opportunities

• Public use data sets available for data collected 

up to 1996 on longitudinal study of Japanese men

in Honolulu.

• Cardiovascular Health Study – four US communities,

aged 65 and older. Substantial amount of data

available for mining. Active diabetes working group.
DMICC ANNUAL REPORT 73 FY 2001

DIABETES MELLITUS INTERAGENCY

COORDINATING COMMITTEE (DMICC)

August 8, 2001

NIH Campus, Lister Hill Auditorium 

Bethesda, Maryland

WELCOME

Dr. Allen Spiegel, Director of the National Institute of

Diabetes and Digestive and Kidney Diseases (NIDDK)

and Chairman of the Diabetes Mellitus Interagency

Coordinating Committee (DMICC), welcomed all to a

meeting that he characterized as a unique event. The

DMICC is charged with coordinating Diabetes

research, not only throughout NIH but throughout all

Department of Health and Human Services (DHHS)

agencies, and will be integrally involved in the followup of the Diabetes Prevention Program (DPP). Dr.

Spiegel explained that the DPP presentation would

include a background overview and reports on the

results and implications of the study. He took the

opportunity to acknowledge all the people involved

in the DPP, including the Principal Investigators,

Program Coordinators, and, most importantly, the

volunteers who participated, some of whom were in

the audience. He then introduced the Chair of the

DPP Study Group, Dr. David Nathan of Massachusetts

General Hospital.

Dr. Nathan reported that the DPP was initiated in

1994 with a planning phase that lasted about 18

months. Recruitment was initiated in mid-1996 and

completed 3 years later, ahead of schedule. The original plan was to conclude the treatment phase in

2002, but this phase was ended about 1 year early

based on the recommendation of the independent

Data Monitoring Board, which concluded in May

2001 that the DPP had succeeded in answering the

major study questions.

STUDY RESULTS 

See HHS News Release as follows:

At least 10 million Americans at high risk for type 2

diabetes can sharply lower their chances of getting

the disease with diet and exercise, according to the

findings of a major clinical trial announced by HHS

Secretary Tommy G. Thompson today, August 8, 2001,

at the National Institutes of Health (NIH).

“In view of the rapidly rising rates of obesity and

diabetes in America, this good news couldn’t come at

a better time,” said Secretary Thompson. “So many of

our health problems can be avoided through diet,

exercise and making sure we take care of ourselves.

By promoting healthy lifestyles, we can improve the

quality of life for all Americans, and reduce health

care costs dramatically.”
DMICC ANNUAL REPORT 74 FY 2001

The same study found that treatment with the oral

diabetes drug metformin (Glucophage®) also reduces

diabetes risk, though less dramatically, in people at

high risk for type 2 diabetes. Participants randomly

assigned to intensive lifestyle intervention reduced

their risk of getting type 2 diabetes by 58 percent. On

average, this group maintained their physical activity

at 30 minutes per day, usually with walking or other

moderate intensity exercise, and lost 5-7 percent of

their body weight. Participants randomized to treatment with metformin reduced their risk of getting

type 2 diabetes by 31 percent.

The findings came from the Diabetes Prevention

Program (DPP), a major clinical trial comparing diet

and exercise to treatment with metformin in 3,234

people with impaired glucose tolerance, a condition

that often precedes diabetes. On the advice of the

DPP’s external data monitoring board, the trial ended

a year early because the data had clearly answered

the main research questions.

Smaller studies in China and Finland have shown

that diet and exercise can delay type 2 diabetes in atrisk people, but the DPP, conducted at 27 centers

nationwide, is the first major trial to show that diet

and exercise can effectively delay diabetes in a

diverse American population of overweight people

with impaired glucose tolerance (IGT). IGT is a condition in which blood glucose levels are higher than

normal but not yet diabetic. (See also Diabetes

Prevention Program: Questions & Answers.) 

Of the 3,234 participants enrolled in the DPP, 45 percent are from minority groups that suffer disproportionately from type 2 diabetes: African Americans,

Hispanic Americans, Asian Americans and Pacific

Islanders, and American Indians. The trial also

recruited other groups known to be at higher risk 

for type 2 diabetes, including individuals age 60 and

older, women with a history of gestational diabetes,

and people with a first-degree relative with type 2

diabetes.

“Lifestyle intervention worked as well in men and

women and in all the ethnic groups. It also worked

well in people age 60 and older, who have a nearly 20

percent prevalence of diabetes, reducing the development of diabetes by 71 percent. Metformin was also

effective in men and women and in all the ethnic

groups, but was relatively ineffective in the older volunteers and in those who were less overweight,” said

DPP study chair Dr. David Nathan of Massachusetts

General Hospital, Boston.

DPP volunteers were randomly assigned to one of 

the following groups: 

• intensive lifestyle changes with the aim of reducing

weight by 7 percent through a low-fat diet and

exercising for 150 minutes a week.

• treatment with the drug metformin (850 mg twice 

a day), approved in 1995 to treat type 2 diabetes.

• a standard group taking placebo pills in place of

metformin. The latter two groups also received

information on diet and exercise.

A fourth arm of the study, treatment with the drug

troglitazone combined with standard diet and 

exercise recommendations, was discontinued in 

June 1998 due to the potential for liver toxicity.

DPP participants ranged from age 25 to 85, with an

average age of 51. Upon entry to the study, all had

impaired glucose tolerance as measured by an oral

glucose tolerance test, and all were overweight, with

an average body mass index (BMI) of 34. About 29

percent of the DPP standard group developed diabetes during the average follow-up period of 3 years.

In contrast, 14 percent of the diet and exercise arm

and 22 percent of the metformin arm developed diabetes. Volunteers in the diet and exercise arm

achieved the study goal, on average a 7 percent--or

15-pound-- weight loss, in the first year and generally sustained a 5 percent total loss for the study’s

duration. Participants in the lifestyle intervention

arm received training in diet, exercise (most chose

walking), and behavior modification skills.
DMICC ANNUAL REPORT 75 FY 2001

Can the interventions prevent diabetes altogether?

“We simply don’t know how long, beyond the 3-year

period studied, diabetes can be delayed,” says Dr.

Nathan. “We hope to follow the DPP population to

learn how long the interventions are effective.” The

researchers will analyze the data to determine

whether the interventions reduced cardiovascular

disease and atherosclerosis, major causes of death 

in people with type 2 diabetes.

“Every year a person can live free of diabetes means

an added year of life free of the pain, disability, and

medical costs incurred by this disease,” said Dr. Allen

Spiegel, director of the National Institute of Diabetes

and Digestive and Kidney Diseases (NIDDK), which

sponsored the DPP. “The DPP findings represent a

major step toward the goal of containing and ultimately reversing the epidemic of type 2 diabetes in

this country.”

Diabetes afflicts more than 16 million people in the

United States. It is the main cause of kidney failure,

limb amputations, and new onset blindness in adults

and a major cause of heart disease and stroke. Type 2

diabetes accounts for up to 95 percent of all diabetes

cases. Most common in adults over age 40, type 2

diabetes affects 8 percent of the U.S. population age

20 and older. It is strongly associated with obesity

(more than 80 percent of people with type 2 diabetes

are overweight), inactivity, family history of diabetes,

and racial or ethnic background. Compared to

whites, black adults have a 60 percent higher rate 

of type 2 diabetes and Hispanic adults have a 90 

percent higher rate.

The prevalence of type 2 diabetes has tripled in the

last 30 years, and much of the increase is due to the

dramatic upsurge in obesity. People with a BMI of 30

or greater have a five-fold greater risk of diabetes

than people with a normal BMI of 25 or less.

To date, the cost of the DPP is $174.3 million. The

DPP is funded by the National Institute of Diabetes

and Digestive and Kidney Diseases, the National

Institute of Child Health and Human Development,

the National Institute on Aging, the National Center

on Minority Health and Health Disparities, the

National Center for Research Resources, the Office 

of Research on Women's Health, and the Office of

Behavioral and Social Science Research within the

NIH. Additional funding and support was provided

by the Centers for Disease Control and Prevention,

the Indian Health Service, and the American Diabetes

Association. The study also is funded in part through

a Cooperative Research Development Agreement

(CRADA) with Bristol Myers Squibb. Other sources 

of corporate support include Merck and Company,

Merck Medco, Hoechst Marion Roussell, Lifescan,

Slimfast, Nike, and Health-O-Meter.

Contact: NIDDK 301-496-3583

Joan Chamberlain

Jane DeMouy
DMICC ANNUAL REPORT 76 FY 2001

PRESENTERS

Sarah Fowler, PhD

Director

Diabetes Prevention Program Coordinating Center

Department of Biostatistics

The George Washington University

6110 Executive Boulevard, Suite 750

Rockville, MD 20852

Phone: (301) 881-9260

Fax: (301) 881-8752

E-mail: fowler@biostat.bsc.gwu.edu

Judith Fradkin, MD

Director

Division of Diabetes, Endocrinology 

and Metabolic Diseases

National Institute of Diabetes and Digestive 

and Kidney Diseases, NIH

6707 Democracy Boulevard, Room 689

Bethesda, MD 20892

Phone: (301) 594-8814

Fax: (301) 480-3503

E-mail: fradkinj@ep.niddk.nih.gov

Wilred Y. Fujimoto, MD

Other Investigator

Division of Metabolic, Endocrinology and Nutrition

University of Washington

Health and Sciences Building, Box 356426

Seattle, WA 98195-6426

Phone: (206) 543-3486

Fax: (206) 616-4341

E-mail: wilfuji@u.washington.edu

Richard Hamman, MD, DrPH

William C. Knowler, MD, DrPH

Chief, Diabetes and Arthritis 

Epidemiology Section

Phoenix Epidemiology and Clinical Research Branch

National Institute of Diabetes and Digestive 

and Kidney Diseases, NIH

1550 East Indian School Road

Phoenix, AZ 85014

Phone: (602) 200-5206

Fax: (602) 200-5225

E-mail: knowler@nih.gov

David M. Nathan, MD

Study Chairman and Principal Investigator

Diabetes Research Center

Massachusetts General Hospital

50 Staniford Street, Suite 340

Boston, MA 02114

Phone: (617) 726-2875 or (617) 726-2066

Fax: (617) 726-6781

E-mail: dnathan@partners.org

Allen M. Spiegel, MD

Director

National Institute of Diabetes and Digestive 

and Kidney Diseases, NIH

Building 31, Room 9A52

Bethesda, MD 20892

Phone: (301) 496-5877

Fax: (301) 402-2125

E-mail: spiegela@extra.niddk.nih.gov

Elizabeth Walker, PhD

Rena Wing, PhD

Principal Investigator

University of Pittsburgh

Diabetes Prevention Program

3600 Forbes Avenue

Iroquois Building, Suite 606

Pittsburgh, PA 15213

Phone: (412) 647-5200

Fax: (412) 647-1771

E-mail: rwing@lifespan.org
DMICC ANNUAL REPORT 77 FY 2001

DIABETES PREVENTION INITIATIVES: 

THE DMICC TASK FORCE

August 9, 2001

NIH Campus, Lister Hill Auditorium 

Bethesda, Maryland

BACKGROUND

At the request of Bill Raub, Deputy ASPE, a meeting

of the DMICC was held on August 6, 2001, to discuss

diabetes prevention initiatives for presentation to 

the Secretary. Dr. Raub explained the background of

this request and defined two parallel activities: a) a

longer term effort to develop a set of coordinated initiatives for consideration as part of the FY’03 budget;

b) a “fast-track” effort to develop bold new initiatives

in which the Secretary could play a personal role 

and which could be implemented by 2002. Dr. Raub

requested that responses for the latter effort be 

sent to Lily Engstrom, OS, by Monday August 13th.

The following DMICC members (N. Armstrong, NINR,

P. Dudley, NEI, C. Dutta, NIA, M. Eberhardt, CDC, J.

Fradkin, NIDDK, S. Garfield, NIDDK and Executive

Secretary of the DMICC, G. Grave, NICHD, R. Knazek,

NCRR, P. Savage, NHLBI, with B. Bowman, M.

Engelgau, and F. Vinicor, CDC by conference call) met

on August 9th to develop a coordinated response. A.

Spiegel, Director of NIDDK and Chair of the DMICC,

cconvened the meeting that also included J. Gallivan,

NIDDK and codirector of the National Diabetes

Education Program (NDEP), and W. Johnson-Taylor,

NIDDK and NIH Division of Nutrition Research

Coordination. Not present but included on the Task

Force are K. Acton, IHS, P. Blackshear, NIEHS, and D.

Stryer, AHRQ.

The group agreed that any initiative proposed should

have a solid scientific basis, and as emphasized by

Dr. Raub, should have an evaluation component. The

group felt that evaluation measures should first

assess the degree to which a message or program

had reached its target audience, and second, assess

the degree to which members of the target audience

had put the message or program into action. Given

the time frame involved and the nature of the initiatives, more definitive health outcome measures such

as incidence of obesity and diabetes would only be

assessed as part of ongoing efforts such as NHANES.

The group also agreed that primary prevention of

diabetes should be a major focus of the initiative

based on the recent results of the Diabetes

Prevention Program (DPP). In fact, the Secretary, in

announcing the results of the DPP, stated that he was

creating a Task Force to make recommendations on

how to implement these results on a wider scale. The

DMICC working group constitutes that Task Force.

The group also identified some possible short-term

initiatives directed toward optimization of diabetes

management, i.e. secondary and tertiary prevention,

but concluded that more definitive efforts in this

area, as well as on the issue of recommendations for

screening for impaired glucose tolerance and undiagnosed diabetes, should be part of the longer-term

effort directed toward the FY’03 budget. Also

deferred was consideration of health coverage issues

for such screening and for programs in diet and 

exercise counseling.

The initiatives proposed below focus largely on programs to increase physical activity in Americans of

all ages based on the rationale that combating the

epidemic of obesity and type 2 diabetes will require

significant changes in lifestyle across all age groups,

and that exercise programs lend themselves better to

direct involvement of the Secretary than do programs

focused on dietary change.
DMICC ANNUAL REPORT 78 FY 2001

PROPOSED INITIATIVES

1. An HHS-wide initiative to increase physical activity of all employees. Such a program lends itself

best to direct involvement of the Secretary, but

could be extended by having him challenge other

Cabinet Departments, as well as companies in the

private sector. If successfully broadened, such an

initiative could target a very large population of

working-age adults. A number of suggestions

regarding specific components included provision

of additional time during or outside of lunch periods for group exercise, and provision of incentives

for increases in physical activity which could

include help in defraying cost of health club membership. Also provision of increased exercise facilities, showers, etc. on site. Additional ideas included making stairs in workplaces more user-friendly

and more heavily used.

2. An effort to reinstate physical education programs

in schools at all levels. The elimination of such

programs correlates with the upsurge in obesity

among youth. While this of course does not prove

causality, most members of the group felt that this

would be an important goal. The Secretary’s challenge to Governors of each state to reinstate physical education in schools would be a dramatic step

that could achieve significant results.

3. Consideration of the Head Start program as a

venue for instruction in the importance of physical

activity (and if possible, good diet). The Head Start

program involves children 3-5 and their parents

who typically come from groups disproportionately affected by diabetes. The program, moreover, is

administered by HHS, offering the Secretary a

ready opportunity to shape it. There may be barriers relating to cost (the program already costs in

excess of $4 billion/year), but close scrutiny of the

program may offer cost-effective approaches to

incorporating exercise and diet instruction.

4. Several representatives offered suggestions regarding school and community-based programs involving instruction in healthy lifestyles. Some of these 

may lend themselves better to the initiatives to 

be suggested for FY’03, but one example suggested 

an award from the Secretary (similar to the “AllAmerican town concept) for those communities

achieving certain goals in terms of increased 

physical activity and/or decreased obesity. A more

detailed description of school and communitybased programs is included as an attachment.

5. Older Americans represent a group at highest risk

for diabetes and therefore an important target for

prevention efforts. I attach two documents: one

that outlines the rationale for targeting the elderly,

and another, as an example of a specific intervention program, that details a well-developed exercise program from NIA targeting those over 50. For

the latter, I have omitted a lengthy set of references, but these can be provided if so desired. Dr.

Dutta, NIA, will also be sending separately to L.

Engstrom the exercise book and video described in

the attachment. Similar programs targeting other

age groups can be developed and fuller descriptions provided if so desired.

6. The National Diabetes Education Program (NDEP),

a joint program of NIH and CDC, plans a major

expansion of its activities. A major goal is to

improve management of diabetics by launching a

“Know your ABC’s” campaign (hemoglobin A1C,

blood pressure, and cholesterol). An attached document lists a number of bullet items in which the

Secretary could promote NDEP activities.

7. CDC reps propose that the Secretary publicly

launch the Diabetes and Women’s Health initiative

at the 2001 Annual Meeting of the American Public

Health Association in Atlanta, GA in Oct. 2001.
DMICC ANNUAL REPORT 79 FY 2001

PROGRAM PROPOSALS SUMITTED BY

PARTICIPATING AGENCIES AND INSTITUTES

Proposal 1: 

Exercise: It Works At Any Age

The health picture of older Americans improved

steadily through the last century. But many of those

age 65 and older still face chronic health conditions.

In general, African Americans, Native Americans, and

Hispanics are disadvantaged relative to whites on

most health indices. Moreover, our national preoccupation with youth makes seniors almost invisible

when it comes to messages of healthy lifestyles.

As the number of older people explodes, now is the

time to change outmoded attitudes and to promote

disease prevention to older people, especially members of special populations. It is a fact that you are

never too old to start a healthier lifestyle. And, as 

one Director of the National Institute on Aging has

said, “If you could pack exercise in a pill, it would 

be the single best medicine available.”

Substantial research data exist to document the benefits of exercise (Tab 1 omitted for the sake of brevity). These include the role of exercise in preventing

heart disease, type II diabetes, stroke, colon cancer,

osteoporosis, depression, falls and disabling injuries,

and even changes in cognition and possibly the onset

of Alzheimer’s disease. Despite the growing list of

benefits of exercise, statistics show that few older

people engage in regular physical activity. Most people know that exercise is good for them. Somehow,

though, older adults have been left out of the picture.

Now is the time to change this picture! 

Within the HHS, the National Institute on Aging (NIA)

has already developed the disease-prevention message and the tools (Tabs 2 and 3) to begin a major

exercise and physical activity campaign targeted to

seniors and, particularly, members of special populations. The NIA has a research-based, road-tested

exercise program designed especially for older

adults. Supporting materials include a complete 

exercise guide and fact sheets in Spanish and

English, an exercise video, a Spanish-language exercise fotonovela, a special internet website designed

for seniors based on NIA cognitive research done in

conjunction with the National Library of Medicine

(Tab 4), posters, shoelaces, and prescription pads for

health providers. The prestige of the Secretary and

the authority of his office hold great sway with older

Americans. A sustained 1-year effort by the Secretary

to promote the health message – Exercise: It Works

at Any Age – would further this important effort to

promote lifestyle change. How? In support of

Secretary Thompson’s deep commitment to preventive measures and a healthy lifestyle, the NIA proposes the development of the Secretary’s Fitness

Calendar for Seniors. The calendar, with a slogan and

suggested spokesperson for each month, would

include a message from the Secretary. Promotional

radio spots will be produced and distributed in concert with other HHS agencies such as the Administration on Aging and the Center for Medicare

Services. The calendar (Tab 5) would be annotated

with suggestions for increasing physical activities

during the month, a suggested regimen, model schedules, and even a certificate of acknowledgement from

the Secretary. The NIA has also outlined potential

strategies to evaluate the outcome of this initiative,

should it go forward (Tab 6). The commitment to 

promote the exercise message to special populations

of seniors would bring much-needed disease-prevention messages to frequently ignored seniors.
DMICC ANNUAL REPORT 80 FY 2001

TAB 2 

Statistics on Current Distribution of 

Exercise Program

Exercise: A Guide from the National Institute on Aging

(80-page book)

441, 900 books printed since 1998

397,018 books disseminated to date

Exercise: A Video from the National Institute on Aging

(48 minute, close-captioned VHS)

33,572 videotapes sold (cost recovery)

Marketing tools used to promote the book

Promotional shoelaces

Print ad slicks

Press releases

Film clip on NIA Website

Partial animation of exercises on NIA website

Exercise poster with Senator John Glenn

Public service announcement (Emmy nomination)

Prescription pads for health professionals

Flyers

Postcards

Exhibit

TAB 3 

Exercise: A Guide from the National Insitute 

on Aging

NIA’s exercise program targets aging baby boomers

and seniors – 71 million Americans are 50 years or

older. Research shows that staying active is essential

to overall good health in aging. Increasingly, scientists are learning that regular exercise prevents many

of the disabilities and illnesses common in older people.

NIA’s exercise program emphasizes:

• endurance exercises, which increase stamina and

help delay or prevent diabetes, colon cancer, heart

disease and stroke.

• strength exercises, which increase metabolism, help

control weight, and regulate blood sugar. Studies

show that they also may help prevent osteoporosis.

• flexibility exercises, which help prevent and aid

recovery from injuries.

• balance exercises, which help prevent falls 

– a major cause of broken hips and other injuries 

that lead to disability and loss of independence.
DMICC ANNUAL REPORT 81 FY 2001

Despite the growing list of benefits of exercise for

older adults, statistics show that few older people

engage in regular physical activity. By age 75, for

example, about one in three men and one out of every

two women do not engage in any of the types of

physical activities that help prevent disease and disability. Research has shown that even very frail older

people in nursing homes can increase their strength

by more than 100 percent through simple musclebuilding exercises. The long list of benefits that aerobic exercise confers on cardiovascular health is well

established. Recent studies also have shown a possible connection between exercise and prevention of

dementia.

The guidelines and exercises included Exercise: 

A Guide from the National Institute on Aging have

been scientifically approved. To ensure the most

accurate and comprehen-sive information possible,

NIA convened a panel of internationally renowned

experts in the field of exercise and aging. This guide

is based on their recommendations and is recognized

as a state-of-the-art guide to exercise for older people.

It includes exercises that older adults can perform 

at home, without expense, to improve strength,

endurance, flexibility, and balance, as well as a detailed

plan to develop a safe, effective exercise program.

Other chapters provide information about safety,

nutrition, motivation, and how to monitor progress.

An updated appendix provides a list of resources for

readers with special health concerns, such as diabetes

and arthritis, and organizations that offer exercise

programs especially for older people.

An accompanying 48-minute video takes viewers

through an easy-to-follow workout of stretching,

balance, and strength-training exercises found in

Exercise: A Guide from the National Institute on

Aging. The video features Margaret Richard, star of

Body Electric, PBS television’s popular exercise show.

TAB 4

Description of Project Teens Teaching 

Elders on the Internet

In January 2002, the National Institute on Aging

(NIA) will become part of an intergenerational program by which teenagers teach older people how to

use the Internet and gain access to senior-friendly

Web Sites. The interactive Web Site on exercise for

older people is being developed by the NIA and the

National Library of Medicine. It will include online

videos showing various exercises being done by the

Department of Health and Human Services Secretary

Tommy G. Thompson, if willing, and eight Directors

from the National Institutes of Health. It will also

include videos on exercise motivation, correct form,

and frequency. The Website navigation, readability

and teaching methods are based on sound research

and use ability tests done on technology and older

people. The Web Site will serve as a prototype for

Web Sites geared toward older people.

Teens Teaching Internet Skills was developed by the

USDA Cooperative State Research, Education and

Extension Service (CSREES), the Center for

Medicare/Medicaid Services (CMS) and local 4-H

Youth Technology Team leaders. USDA-CSREES coordinates national 4-H programs and HCFA administers the federal Medicare program. Between

September 1999 and April 2000, 4-H Youth

Technology Corps members led successful pilot

training sessions in Connecticut, Florida, Iowa,

Virginia, Maryland and Washington State. Based on

the success of the pilot sessions, leaders from USDA,

CMS and 4-H are working to bring TTIS programs to

communities around the country.
DMICC ANNUAL REPORT 82 FY 2001

TAB 5

The Secretary’s Fitness Calendar for Seniors

Exercise: It Works At Any Age

(month, slogan, suggested spokesperson)

Oct. Don’t Play Tricks On Yourself – Exercise 

– Bill Cosby

Nov. Exercise – Your Body Will Thank You 

– Tina Turner

Dec. Give Yourself A Holiday Gift 

– Ruby Dee & Ossie Davis

Jan. Resolve To Exercise 

– Dick Clark

Feb. Have A Healthy Heart – Exercise 

– Maria Tallchief

Mar. Get In Training – Exercise 

– Hank Aaron

April Exercise – It’s Not Too Taxing 

– JC Watts

May Increase Your Independence – Exercise 

– Rita Moreno 

June Graduate To A Higher Level Of Exercise 

– Josefina Carbonell, Ass’t Secretary for Aging

July Burst Into Fitness 

– Lee Trevino

Aug. Don’t Take A Vacation From Exercise 

– Pat Morita

Sept. Fall In Step: Start an Exercise Program 

– Former President George Bush

TAB 6

Evaluation Plan

Exercise: It Works At Any Age

In addition to tracking the distribution of the 

exercise guide and video, NIA currently is conducting

a number of projects to evaluate these materials 

and their use. Similar strategies would be planned

to evaluate the Secretary’s Calendar and public

awareness campaign.

Current Projects to Evaluate Exercise:

A Guide from the National Institute on Aging

• Duke University Medical Center currently is conducting an evaluation of NIA’s exercise guide as

part of a larger study to evaluate whether a telephone-counseling program is effective in improving

physical activity and diet among elderly cancer

patients with early-stage disease – behavior

changes that should ultimately improve their physical function. Specifically, they are evaluating

whether the exercise book is easy to understand,

whether the graphics in the book clearly demonstrate how to perform the exercises correctly, and

whether the book motivates participants to exercise. Approximately 420 early-stage breast and

prostate cancer patients 65 and older are participating in this evaluation project.

• NIA currently is conducting a feasibility study to

determine the methodology for an evaluation of the

exercise book and videotape, specifically to discover how the book/video are being used, its role in

changing behavior (both short-term and long-term

behavior changes), and whether modifications to

the book/video might have a positive impact on

users’ ability to maintain exercise as part of a

healthy lifestyle. This feasibility study focuses on

developing a study to answer questions such as:

how are people using the exercise book/video, who

are they, how do the book/video alter users’ personal exercise routines, what other exercise-related

materials might help users sustain a healthy
DMICC ANNUAL REPORT 83 FY 2001

lifestyle, and what suggestions do users have for

improving these products.

Proposed Evaluation Strategies for Exercise: 

It Works At Any Age, The Secretary’s Calendar 

for Seniors

• The NIA Information Center will track numbers 

of calendars distributed and requests generated 

by the Calendar for copies of NIA’s exercise

book/video.

• The NIA Information Center will track the number

of Certificates from the Secretary distributed in

response to mail-back forms provided in the

Calendar.

• NIA will develop a separate web page to record and

respond to feedback/ suggestions for improving the

exercise book/video, as well as collect comments

about the usefulness of the Calendar in promoting

fitness and healthy lifestyles.

• NIA will work with AoA to develop a communitybased approach to evaluate how people are using

the Calendar and its usefulness in motivating older

people to adopt exercise as part of their daily routine. This project also will include component to

evaluate performance and measure progress (for

example, are older people exercising, how long,

how often, and how much is it affecting their 

overall health).

• NIA will track media reports of the Secretary’s promotional appearances on Oprah and other talk

shows and will use a broadcast monitoring service

to track print stories relating to this public awareness campaign.

Proposal 2: 

Prevention of type 2 diabetes and its 

complications in elderly men and women

Type 2 diabetes is very common in the elderly and is

projected to become an even greater problem. There

are reasons to think it could be prevented or at least

postponed by interventions similar to those which

were so successful in the recently completed

Diabetes Prevention Trial.

Using the WHO criteria for diabetes and impaired

glucose tolerance, approximately 50% of U.S. adults

aged 65 years and older have abnormal glucose tolerance. Approximately 20% have diabetes and 30% have

impaired glucose tolerance. These numbers are even

higher among many minority populations. While the

number of people with diabetes will be somewhat

less using the current US ADA criteria for diabetes,

there is little doubt that the elderly are a group at

high risk for progression to diabetes. Moreover, while

diabetes increases the risk for eye and kidney disease, both diabetes and impaired glucose tolerance

increase the risk for development of cardiovascular

disease, the major cause of death in older persons.

Older patients with type 2 diabetes represent a significant component of patients receiving care for end

stage renal disease and a significant portion of those

with serious visual impairment. Diabetes is a major

risk factor for myocardial infarction and death in

this age group.

It is important to note that the problem is increasing

and, unless something is done, will be substantially

greater in future years. There are several factors

which will inevitably increase the numbers of older

women and men with diabetes. The U.S. population is

aging and the numbers of the “old old”, i.e., over 85,

will continue to increase. As life expectancy increases, more members of minority groups at high risk for

diabetes will join the ranks of the elderly. Increasing

obesity and lack of exercise among the middle aged

population will also lead to more people at high risk

for developing diabetes joining the elderly in the

decades to come.
DMICC ANNUAL REPORT 84 FY 2001

Despite the magnitude of the problem, however,

other factors make the elderly a good group to target

for prevention efforts. Although diabetes is common,

in many instances it is mild in older persons, making

them good candidates for responding to diet and

lifestyle changes. Such interventions may be even

more effective in those with impaired glucose tolerance, the milder abnormality treated in the diabetes

prevention trial. It is noteworthy that the best results

in the prevention trial occurred among those over 60

years of age. Older patients are frequently concerned

about their health and often have the time and 

motivation to participate in activities which will be

beneficial. In addition, their membership in organizations such as the American Association of Retired

Persons and participation in activities at local senior

centers, churches, recreation facilities, etc. may facilitate reaching them with public information campaigns and programs to adopt a healthier lifestyle.

Even if such programs only succeed in postponing

the development of diabetes or temporarily improving control of their glucose levels, the anticipated

delay in developing complications of diabetes may

give them several more years of a healthy life.

There may be a need to develop modifications in the

prevention program to maximize its effectiveness

among an elderly population. This is particularly true

if it is provided to the older elderly where the existence of symptomatic heart and vascular disease is

more common. Guidelines will need to be developed

to identify participants who are most likely to benefit

from the program and to also identify those who

might not be able to tolerate the full intervention.

Collaboration with local health care providers will be

important, both to assure patient safety and to attain

their cooperation in encouraging patient participation.

It is proposed that there be two components to the

program 1) a public information campaign encouraging older women and men to eat a healthy diet and

engage in regular physical activity and 2) a group of

demonstration centers (or communities) where a

more systematic effort to assess the best ways to

achieve participation in the intervention (evaluating

both communication methods and cost of the effort)

and any possible adverse effects of participation.

A critical component of the overall program is to

document its effectiveness. While there is no doubt

that the diabetes prevention trial was a remarkable

success, it is crucial to evaluate the ability to translate such research interventions into programs that

are practical and affordable for use in the health

care practice or community setting. The NIH and CDC

should collaborate to develop goals for the program,

methods to evaluate its success and procedures for

modifying strategies and incorporating 

new relevant information as it becomes available.

Translation problems may differ in different communities - the local environment may have a major

effect upon the ability to successfully implement 

the prevention program.

A final advantage of an effort at diabetes prevention

in older women and men is that a good diet and 

moderate exercise are likely to have several beneficial

effects in this population beyond the prevention of

diabetes. On the basis of existing scientific studies,

beneficial effects may be anticipated on blood pressure, cardiovascular disease and the individual 

participant’s sense of well being.
DMICC ANNUAL REPORT 85 FY 2001

Proposal 3: 

School and Community-based Interventions

Type 2 diabetes is now a health problem for all age

groups, although it continues to be more prevalent in

the adult and older adult years. Children who develop type 2 diabetes, however, have a longer life span

to cope with a complex and difficult disease and to

develop complications at an earlier age. Prevention 

or delay of the onset of type 2 diabetes in those at

risk is an important societal concern. The following

are some potential approaches that lend themselves

to immediate implementation. These suggestions may

be used to target at-risk populations or be opened 

to the community citizens as a whole.

1. Encourage schools to lead their community in

leading healthier lifestyles through good nutrition

and physical activity. Encourage whole community

involvement. Communities could show, through

common measures, their degree of achievement of

their healthy living goals each year. Communities

showing the most improvement might be awarded

certificates of achievement and be recognized in

the news. A healthy lifestyle achievement award

could be given to the most improved communities

by Secretary Thompson. One example of a school

activity to encourage community involvement is to

hold family “healthy living” evenings during the

Fall or Spring months each year to reach parents,

children, and all community citizens. Make it

attractive enough to encourage attendance by all

groups (including low income and minorities).

Speakers or panel presentations could provide

information about nutrition and physical activity

and how a healthier lifestyle will improve fitness,

emotional well-being, and help prevent/delay type

2 diabetes. Entertainment portion could include

fun physical activity events/how to count

pulses/other useful skills. Community businesses

may want to show support in various ways including financing community-based physical activity

events. Grocery stores could place clever signs over

healthy foods. The communities would undoubtedly be creative in developing motivation enhancements and social support.

2. Develop an interactive computer program to install

in school or home computers. The program would

be based on many that are already available to the

public. This program would focus on helping the

child or adolescent to develop food and physical

activity goals and track their progress. For example, the youngster might enter their weight and

target weight, their current minutes of physical

exercise and their target minutes, exercise type,

and various other information. The program would

allow periodic (daily or weekly) entry. Charts and

graphics could display progress towards the goal.

Refinement of goals and other inputs would be

possible as the youngsters learn more about their

lifestyle behaviors. A certificate of achievement

should pop up and be available to print at the

achievement of each goal.
DMICC ANNUAL REPORT 86 FY 2001

3. Develop a public health information program 

for schools that targets all grades from preschool 

to 12th grade. The program should combine food

intake and exercise in tandem as opposed to 

separate programs for each. For example,

• Develop charts aimed at school-agers that show

how much physical activity (duration, intensity)

is required to burn various calorie amounts (100,

200, 300, etc.). The charts could be 3 ring binder

size so students could place them in a notebook.

• Develop menus for each major ethnic group 

showing realistic but healthy portion sizes of 

common ethnic foods. Portion sizes could be 

varied by age groupings

• The menus in school cafeterias should reflect 

recommended food intake (type and calories).

Unhealthy food choices in vending machines 

should be limited.

• Physical activity should be re-instated as a

required activity in all schools. Healthy food 

choices should be a part of the physical 

activity curriculum content.

4. Develop an educational program to teach teachers

how to integrate healthy lifestyle content and

behaviors in their curriculum. Schools could

choose an integrated approach (healthy lifestyle

content in all appropriate courses) or specific

classes for students (physical activity and nutrition classes).

Proposal 4: 

National Diabetes Education Program

The purpose of the National Diabetes Education

Program (NDEP), a joint initiative of the NIH and

CDC, is to improve the treatment and outcomes of

people with diabetes, to promote early diagnosis,

and ultimately, to prevent the onset of diabetes. The

NDEP has embarked on public and private education

and information programs focusing on increasing

diabetes awareness, with emphasis on prevention of

complications, and dissemination of recent research

findings. Through its partnership network, the NDEP

will provide support and promote findings from the

Diabetes Prevention Program (DPP), similar to activities that have promoted results of the Diabetes

Control and Complications Trial (DCCT) and other

clinical trials.

For people with diabetes:

• Secretary Thompson challenges all Americans 

with diabetes to know their ABC numbers and take

action to lower their risk of diabetes complications,

particularly heart disease and stroke. People with

diabetes would have A1C, blood pressure and blood

cholesterol tests done and schedule a visit with an

appropriate health care provider to begin to take

steps to lower these numbers toward target levels

that have been proven effective in preventing complications.

• Worksite programs would be available in all federal

agencies to provide diabetes education, support

groups and physical activity opportunities for people with diabetes. Federal agencies could use the

NDEP diabetes worksite kit that will provide tools

for businesses to use for creating and supporting

diabetes education programs as well as motivation

for implementation of these activities by assessing

the impact of diabetes on their business.
DMICC ANNUAL REPORT 87 FY 2001

For people at risk for diabetes Secretary Thompson

would issue challenges for communities and organizations and provide incentives and awards to those

that report accomplishments:

• Partner with corporations to provide support and

resources for exercise programs in the workplace

• Partner with local community centers and neighborhood groups to provide opportunities to 

exercise in a safe environment without costly 

membership fees. Partner with YMCA, Girl/Boy

Scouts, Boys and Girls Clubs to support/subsidize

programs for children.

• Provide education and training for lifestyle interventions (diet, physical activity, behavior modification) that were successful in DPP with services to

be covered by Insurance companies, beginning 

with Medicaid, Medicare.

• Schools to provide structured physical activity

through physical education and/or after school programs, and support services for children to attend

sessions (buses, supervision, etc.). Recreational

group and individual sports should be encouraged

and supported, not only competitive sports. Partner

with President's Council on Fitness, Head Start.

• America Walks Program. Neighborhoods organize

evening group walks. Low cost pedometers distributed through schools, communities with recognition for miles walked.

• School Lunch Program to promote healthy eating

through school lunch, snacks, etc. Partner with

PTSA, Association of School Board, Dept. of

Education

• Partner with WIC, Food stamps, 5 -A- Day to 

get fresh fruits and vegetables available-Dept.

of Agriculture

• National Community fitness day- held in communities across the country to encourage and support

family fitness

• National Worksite fitness programs - fitness 

contests/programs among offices and agencies.

“Take the stairs” day- one day per week to 

encourage activity.

• National Diabetes Prevention Day/Week in cities

and communities across the country. Include fitness

events, walk-a-thons, healthy eating activities,

community gardening, etc. Get kids involved.

• Diabetes Prevention All-Stars – Sec. Thompson

meets with baseball, basketball, Olympians, etc.

commissioners, players to encourage fitness and

working out with children

• President Bush promotes fitness/diabetes 

prevention during baseball on White House lawn

• Include Prevention education for diabetes and 

other diseases in President's Education Plan

• Partner with Office on Aging, AARP etc. to 

support fitness and healthy eating for older adults.

Retirement communities, military programs to 

support fitness programs for adults of all ages.

• The “Sisters Together” project has developed a 

complete community health awareness program 

to encourage African American women to be more

physically active and eat better to prevent obesity.

The NIH launch of this national program will be

held on Sept. 15 in D.C. at the Franklin D. Reeves

Center. Secretary Thompson could use this event 

to challenge communities to adopt the Sisters

Together program, enlist local community champions to promote the program and provide incentives/recognition for communities who enlist and

complete local fitness events planned throughout

the year. Sisters Together also encourages families

to exercise together.
APPENDICES
DMICC ANNUAL REPORT 91 FY 2001

PUBLIC HEALTH SERVICE: 

Interagency Coordinating Committees

Sec.429. [285c—3] 

(a) For the purpose of —

(1) better coordination of the research activities of all the national research institutes relating to 

diabetes mellitus, digestive diseases, and kidney, urologic, and hematologic diseases; and

(2) coordinating those aspects of all Federal health programs and activities relating to such diseases 

to assure the adequacy and technical soundness of such programs and activities and to provide 

for the full communication and exchange of information necessary to maintain adequate 

coordination of such programs and activities;

the secretary shall establish a Diabetes Mellitus Interagency Coordinating Committee, a Digestive Diseases

Interagency Coordinating Committee, and a Kidney, Urologic, and Hematologic Diseases Coordinating Committee

(hereafter in this section individually referred to as a “Committee”).

(b) Each committee shall be composed of the Directors of each of the national research institutes and 

divisions involved in research with respect to the diseases for which the Committee is established,

the Division Director of the Institute for the diseases for which the Committee is established, the 

Chief Medical Director of the Veterans’ Administration,1 and the Assistant Secretary of Defense for

Health Affairs (or the designees of such officers) and shall include representation from all other

Federal departments and agencies whose programs involve health functions or responsibilities 

relevant to such diseases, as determined by the Secretary. Each Committee shall be chaired by the

Director of NIH (or the designee of the Director). Each committee shall meet at the call of the 

chairman, but not less often than four times a year.

(c) each Committee shall prepare an annual report for —

(1) the Secretary;

(2) the Director of NIH; and

(3) the Advisory Board established under section 430 for the diseases for which the Committee 

was established, detailing the work of the Committee in carrying out paragraphs (1) and 

(2) of subsection (a) in the fiscal year for which the report was prepared. Such report shall be 

submitted not later than 120 days after the end of each fiscal year.

1 The reference is deemed to be a reference to the Under Secretary for Health of the Department of Veteran Affairs.

See section 302 (e)(1) of Public Law 102-405(106) Stat. 1985 and section 10(4) of Public Law 100-527 (102 Stat.2641).

APPENDIX A
DMICC ANNUAL REPORT 93 FY 2001

DIABETES MELLITUS INTERAGENCY COORDINATING COMMITTEE

ROSTER OF MEMBERS (2001)

CHAIRMAN

Allen Spiegel, MD

Director

National Institute of Diabetes and 

Digestive and Kidney Diseases

National Institutes of Health

Building 31, Room 9A52

9000 Rockville Pike

Bethesda, MD 20892

Phone: (301) 496-5877 

Fax: (301) 496-9943

E-mail: allens@amb.niddk.gov

EXECUTIVE SECRETARY

Sanford Garfield, PhD

Senior Advisor, Biometrics and Behavioral Science

National Institute of Diabetes and 

Digestive and Kidney Diseases

National Institutes of Health

6707 Democracy Boulevard, Room 685

Bethesda, MD 20892-5460

Phone: (301) 594-8803

Fax: (301) 480-3503

E-mail: garfields@extra.niddk.nih.gov

MEMBERS

Agency for Healthcare Research and Quality

Daniel B. Stryer, MD

Medical Officer

Center for Outcomes and Effectiveness Research

6010 Executive Boulevard, Suite 300

Rockville, MD 20852

Phone: (301) 594-4038

Fax: (301) 594-3211

Email: dstryer@ahrq.gov

Centers for Medicare and Medicaid Services

John P. Lanigan

Health Insurance Specialist

Office of Professional Relations

Hubert Humphrey Building

Room 435H

Washington, DC 20201

Phone: (202) 690-7418

Fax: (202) 401-7438

Email: jlanigan@hcfa.gov

APPENDIX B
DMICC ANNUAL REPORT 94 FY 2001

Center for Disease Control and Prevention

Frank Vinicor, MD

Director, Division of Diabetes Translation

4770 Buford Highway, NW MSK-10

Atlanta, GA 30341

Phone: (770) 488-5001

Fax: (770) 488-5966

Email: fxv1@cdc.gov

Mark Eberhardt, PhD

Epidemiologist

National Center for Health Statistics

6525 Belcrest Road, Room 730

Hyattsville, MD 20782

Phone: (301) 436-5979, x142

Fax: (301) 436-8459

Email: mse1@cdc.gov

Center for Scientific Review

N. Krish Krishnam, PhD

National Institutes of Health

Two Rockledge Centre

Room 6164

Bethesda, MD 20892

Phone: (301) 435-1041

Fax: (301) 480-2065

Email: krishnak@mail.nih.gov

Department of Health and Human Services

Susan J. Blumenthal, MD, MPA

US Assistant Surgeon General

200 Independence Avenue, SW

Room 719H

Washington, DC 20201

Phone: 202-260-2255

Email: SBlumenthal@osophs.dhhs.gov

Violet Ryo-Hwa Woo, MS, MPH

Program Analyst

Office of Minority Health

5515 Security Lane, Suite 1000

Rockville, MD 20852

Phone: 301-443-9923

Fax: 301-443-8280

Email: vwoo@osophs.dhhs.gov

Food and Drug Administration

Shaio-Wei Shen, MD

Medical Officer, Division of Metabolism 

and Endocrine Drug Products

Parklawn Building, Room 14B-04

5600 Fishers Lane, HFD-510

Rockville, MD 20857

Phone: (301) 827-6378

Fax: (301) 443-9282

Email: shen@cder.fda.gov

Department of Health and Human Services

CAPT Laura McNally

Office of the Administrator

Center for Quality Health Resources and 

Services Administration

Parklawn Building, Room 9-05

Rockville, MD 20852

Phone: (301) 443-0458

Fax: (301) 443-9795

Email: lmcnally@hrsa.gov
DMICC ANNUAL REPORT 95 FY 2001

Indian Health Service

Kelly Acton, MD, MPH

Director, National Diabetes Program

National Institutes of Health

Headquarters Office

5300 Homestead Road, NE

Albuquerque, NM 87110-1293

Phone: (505) 248-4182

Fax: (505) 248-4188

Email: Kelly.acton@mail.ihs.gov

National Center for Complementary 

and Alternative Medicine

Marguerite Evans

Health Science Administrator

6707 Democracy Boulevard

Room 106

Bethesda, MD 20892-5475

Phone: (301) 402-5860

Fax: (301) 480-3621

Email: evansm@od.nih.gov

National Center for Research Resources 

Richard Knazek, MD

Medical Officer

National Institutes of Health

6705 Rockledge Drive

Rockledge 1, Room 6128

Bethesda, MD 20892

Phone: (301) 435-0790

Fax: (301) 480-3661

Email: richardk@ncrr.nih.gov

National Eye Institute

Peter Dudley, PhD

Director, Retinal Diseases Program

National Institutes of Health

6120 Executive Boulevard

Suite 350

Rockville, MD 20892

Phone: (301) 496-0484

Fax: (301) 402-0528

Email: pad@nei.nih.gov

National, Heart, Lung and Blood Institute

Peter J. Savage, MD

Acting Director, Division of Epidemiology 

and Clinical Applications

National Institutes of Health

Rockledge 2, Room 8104

Bethesda, MD 20817

Phone: (301) 435-0421

Fax: (301) 480-1864

Email: savagep@nhlbi.nih.gov

National Human Genome Research Institute 

Elke Jordan, PhD

Deputy Director

National Institutes of Health

31 Center Drive, MSC 2152

Bethesda, MD 20892-2152

Phone: (301) 496-0844

Fax: (301) 402-0837

Email: elkej@mail.nih.gov
DMICC ANNUAL REPORT 96 FY 2001

National Institute on Alcohol Abuse 

and Alcoholism

Vishnudutt Purohit, PhD

National Institutes of Health

6000 Executive Boulevard, Suite 402

Bethesda, MD 20892

Phone : (301) 443-2689

Fax : (301) 594-0673

Email : vpurohit@willco.niaaa.nih.gov

National Institute of Allergy and 

Infectious Diseases

Elaine Collier, MD

Centers Program Director

Division of Allergy, Immunology,

and Transplantation

National Institutes of Health

Soar Building, Room 4a20

9000 Rockville Pike

Bethesda, MD 20892-7640

Phone: (301) 496-7104

Fax: (301) 402-2571

Email: ecollier@niaid.nih.gov

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

Julia Freeman, PhD

Chief, Autoimmunity Section

National Institutes of Health

Building 45, Room 5AS-19F

45 Center Drive, MSC 6500

Bethesda, MD 20892-6500

Phone: (301) 594-5052

Fax: (301) 480-4543

Email: freemanj@ep.niams.nih.gov

National Institute of Biomedical Imaging 

and Bioengineering

Joan Harmon, PhD

Senior Advisor for Program and Acting Director,

Division of Bioengineering

National Institutes of Health

Building 31, Room 1B37, MSC 2077

Bethesda, MD 20892-2077

Phone: (301) 451-6772

Fax: (301) 480-4515

Email: harmonj@nibib.nih.gov

National Institute of Child Health and 

Human Development

Gilman D. Grave, MD

Chief, Endocrinology, Nutrition and Growth Branch

National Institutes of Health

9000 Rockville Pike

Bethesda, MD 20890

Phone: (301) 496-5593

Fax: (301) 480-9791

Email: gg37v@nih.gov

National Institute of Dental and 

Craniofacial Research

Patricia S. Bryant

Director, Behavior, Health Promotion and

Environment Program

National Institutes of Health

Building 45, Room 4AN-24, MSC 6402

Bethesda, MD 20892-6402

Phone: (301) 594-2095

Fax: (301) 480-8318

Email: bryantp@de45.nidr.nih.gov
DMICC ANNUAL REPORT 97 FY 2001

National Institute of Diabetes and 

Digestive and Kidney Diseases

Judith Fradkin, MD

Acting Director, Division of Diabetes,

Endocrinology and Metabolism

National Institutes of Health

6706 Democracy Blvd, Room 689

MSC-5460

Bethesda, MD 20892-5460

Phone: (301) 594-8814

Fax: (301) 480-3503

Email: fradkinj@ep.niddk.nih.gov

National Institute of Environmental 

Health Sciences

Perry Blackshear, MD, Dphil

Director, Office of Clinical Programs

National Institutes of Health

PO Box 12233

NIEHS, MD A2-05

RTP, NC 27709

Phone: (919) 541-4899

Fax: (919) 541-4571

Email: black009@niehs.nih.gov

National Institute of General Medical Sciences

Richard Anderson, MD, PhD

Program Director, Division of Genetics and

Developmental Biology

National Institutes of Health

Natcher Building, Room 2AS-25

45 Center Drive, MSC 6200

Bethesda, MD 20892-6200

Phone: (301) 594-0943

Fax: (301) 480-2228

Email: andersor@nigms.nih.gov

National Institute of Mental Health

Peter Muehrer, PhD

Chief, Health and Behavioral Science

Research Branch

Division of Mental Disorders, Behavioral 

Research and AIDS

National Institutes of Health

6001 Executive Boulevard, Room 6189

MSC 9615

Bethesda, MD 20892-9615

Phone: (301) 443-4708

Fax: (301) 480-4415

Email: pmuehrer@mail.nih.gov

National Institute of Neurological 

Disorders and Stroke

Paul L. Nichols, PhD

Program Director, Systems and Cognitive

Neuroscience Program

National Institutes of Health

6001 Executive Boulevard, Room 2118

Rockville, MD 20892

Phone: (301) 496-9964

Fax: (301) 402-2060

Email: pn13w@nih.gov

National Institute of Nursing Research

Nell Armstrong, PhD, RN

Program Director

National Institutes of Health

Building 45, Room 3AN-12

45 Center Drive, MSC 6300

Bethesda, MD 20892-6300

Phone: (301) 594-5973

Fax: (301) 480-8260

Email: nell_Armstrong@nih.gov
National Institute on Aging

Chhanda Dutta, PhD

Chief, Musculoskeletal Section and Nutrition,

Metabolism, Gastroenterology Section

Geriatrics Program

National Institutes on Health

Gateway Building, Suite 3E327

7201 Wisconsin Avenue

Bethesda, MD 20893

Phone: (301) 435-3048

Fax: (301) 402-1784

Email: cd23z@nih.gov

National Institute on Deafness and 

Other Communication Disorders

Barry J. Davis, PhD

Scientific Programs Branch

Division of Extramural Research

National Institutes of Health

6120 Executive Boulevard

Rockville, MD 20892-7180

Phone: (301) 402-3464

Fax: (301) 402-6251

Email: barry_davis@nih.gov

National Institute on Drug Abuse

Jag H. Khalsa, PhD

Pharmacologist Health Administrator

Center on AIDS and other Medical 

Consequences of Drug Abuse (CAMCODA)

6001 Executive Boulevard

Room 5098, MSC 9593

Bethesda, MD 20892-5953

Phone: (301) 443-1801

Fax: (301) 443-4100

Email: jk98p@nih.gov

National Library of Medicine

Elliot R. Siegel, PhD

Associate Director of Health Information 

Program Development

National Institutes of Health

8600 Rockville Pike

Bethesda, MD 20817

Phone: (301) 496-8834

Fax: (301) 496-4450

Email: siegel@nlm.nih.gov

Veterans Health Administration

Leonard M. Pogach, MD, MBA

East Orange Veterans Affairs Medical Center

385 Tremont Avenue

East Orange, NJ 07018

Phone: (973) 676-1000, ext. 1693

Fax: (973) 395-7092

Email: Leonard.pogach@med.va.gov

DMICC ANNUAL REPORT 98 FY 2001