What is the Longitudinal Assessment of

Bariatric Surgery (LABS)?

The Longitudinal Assessment of Bariatric Surgery

was originally known as the Bariatric Surgery

Clinical Research Consortium. LABS is a National

Institutes of Health (NIH)-funded consortium of six

clinical centers and a data coordinating center

working in cooperation with NIH scientific staff to

plan, develop, and conduct coordinated clinical,

epidemiological, and behavioral research in

bariatric surgery.

What is bariatric surgery?

Bariatric surgery restricts stomach size and/or leads

to decreased absorption of nutrients. These procedures can have dramatic health benefits, such as

improved control of blood sugar or even reversal of

type 2 diabetes, but they also carry substantial

risks, including death.

How many people have had bariatric

surgery?

According to the American Society for Bariatric

Surgery (ASBS), the number of procedures

increased from about 16,000 in the early 1990s to

more than 103,000 in 2003.

Why did the National Institute of

Diabetes and Digestive and Kidney

Diseases (NIDDK) launch LABS?

■ A majority of U.S. adults are overweight or

obese, with more than 30 percent of adults

considered obese (Body Mass Index [BMI]

greater than 30). An increasing number of

adults are considered extremely obese (BMI

greater than or equal to 40).

■ Numerous studies have shown that behavioral

therapy to improve diet and physical activity

can lead to weight loss of approximately five to

ten percent over four to six months.

■ When a person loses weight, obesity-related

conditions such as high blood pressure and

type 2 diabetes improve, but if a person regains

weight, these benefits are lost.

■ In many cases, a person who regains weight

ends up weighing more than he or she weighed

before the intervention. Doctors need effective

weight-loss methods for people with extreme

obesity and effective ways to maintain longterm weight loss.

■ Currently, the most effective means of losing

substantial weight and maintaining that weight

loss is through bariatric surgery.

■ Although an increasing number of persons with

extreme obesity are undergoing bariatric surgical procedures, there has been little systematic

research to help determine its risks and benefits

or to provide guidance on appropriate patient

selection. To facilitate research in this area,

NIDDK established LABS.

What is the goal of LABS?

LABS has brought together experts in bariatric surgery, obesity research, internal medicine,

endocrinology, behavioral science, outcomes

research, epidemiology, and other relevant fields to

plan and conduct studies that will analyze the risks

and benefits of bariatric surgery and its impact on

the health and well-being of patients with extreme

obesity, and identify the kinds of patients who are

most likely to benefit.
How will LABS accomplish its goal?

The consortium has developed a database for collecting standardized information on patients undergoing bariatric surgery at the participating clinical

centers. Rigorously collected information on

patient characteristics, types of surgery, medical

and psychosocial outcomes, and economic factors

will ultimately provide science-based information

on the risks and benefits of bariatric surgery. This

information should lead to rational recommendations for clinical care.

LABS will also support clinical studies that are proposed, designed, and approved by the Steering

Committee (see below). Examples of the types of questions that might be addressed by such studies include:

■ The impact of surgical procedures on conditions

such as insulin resistance and type 2 diabetes.

■ The mechanisms by which bariatric surgery

may enhance long-term weight maintenance.

■ The causes of and potential treatments for obesity.

For example, examining the impact of restrictive

(laparoscopic banding) versus malabsorptive

(gastric bypass or biliopancreatic diversion) surgical

procedures on hormones presumed to affect

appetite may provide insights leading to new,

non-surgical obesity treatments that mimic the

appetite-suppressive effects of surgery.

LABS Centers will also collect data and specimens

for future research. These data will provide a valuable resource for the future study of obesity and its

complications.

How is LABS organized?

■ Through a competitive, peer-reviewed process,

principal investigators at six clinical centers and a

data coordinating center were funded in September

2003. These investigators are listed on page 3.

■ The principal investigators at the clinical centers and data coordinating center and the NIH

project scientist comprise the Steering

Committee, which is the governing body for the

consortium.

■ The Steering Committee has met on a frequent

basis to develop the database and plan the clinical protocols.

■ Investigators, scientists, and clinicians from the

participating centers with relevant expertise are

participating in ongoing committees and working groups.

What is the study timeline for LABS?

■ LABS was funded in September 2003.

■ During the first 18 months, investigators have

worked together to develop the database, plan

the clinical protocols, and obtain appropriate

human subjects approval. The LABS database

started enrolling patients in March 2005.

■ LABS will conduct one or more studies each

year during its five-year funding period, ranging

from small pilot studies to larger studies.

■ Short-term and longer-term studies will be carried out during years 2-4, with continued follow-up and study analysis during the final year.

What funds are available for LABS?

LABS is funded at 3 million dollars per year for five

years, for a total of 15 million dollars. There are

also opportunities for investigators to apply for

additional funding for ancillary studies through a

request for applications (RFA). Information on the

ancillary studies RFA is at:

http://grants2.nih.gov/grants/guide/rfa-files/RFADK-03-022.html.

The Office of Research on Women’s Health

(ORWH) provided funds to be used for LABS

research related to women’s health issues.

Information on the ORWH can be found at:

www4.od.nih.gov/orwh/.

Will LABS provide free bariatric surgery

for study participants?

No. LABS cannot cover the costs of bariatric surgery

or patient care. Study participants must be able to

support the cost of their surgery and related patient

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care through medical insurance or other means.

However, any tests or examinations done solely for

research purposes rather than routine patient care

will be done at no cost to participants.

How can patients get more information

about enrollment in LABS?

For more information about enrollment in LABS,

see: www.niddklabs.org.

In what other ways might LABS help to

advance future obesity research?

■ LABS may provide the preliminary data needed

for future investigator-initiated research on

bariatric surgery and obesity. For example, if

LABS investigators are able to identify metabolic and endocrine changes that take place after

bariatric surgery, this information would allow

researchers to submit independent applications

for full-scale clinical studies.

■ LABS may encourage researchers to study the

causes and treatments of obesity and its related

health problems by providing access to laboratory

specimens and tissues.

■ The presence of coordinated obesity research

efforts at participating institutions may provide

opportunities for research and clinical training

to students in the health professions, as well as

to young investigators.

■ Information on the types of data being collected

in the LABS database (not individual patient information) will be available on the LABS website, so

that other interested clinicians and researchers

can collect similar data on their patients, facilitating additional research on bariatric surgery.

LABS Principal Investigators at the Six

Clinical Centers

Paul D. Berk, MD

Professor of Medicine

Columbia University

Medical Center

630 W. 168th Street

P.O. Box 83 BB912

New York, NY 10029-6574

Anita P. Courcoulas, MD

Director, Minimally Invasive Bariatric and 

General Surgery 

University of Pittsburgh Medical Center 

Division of Thoracic and Foregut Surgery

5200 Centre Avenue, Suite 715

Pittsburgh, PA 1232

David R. Flum, MD, MPH

University of Washington

Department of Medicine 

Department of Surgery 

1959 NE Pacific Street

Box 356410

Seattle, WA 98195-6410

James E. Mitchell, MD

Neuropsychiactric Research Institute

700 1st Avenue South

PO Box 1415

Fargo, ND 58107

Walter J. Pories, MD, FACS

Professor of Surgery and Biochemistry 

Brody School of Medicine

East Carolina University

600 Moye Boulevard 

Greenville, NC 27858 

Bruce M. Wolfe, MD

Oregon Health and Science University

Division of General Surgery BTE223

3181 S.W. Jackson Park Road

Portland, OR 97239-3098

Data Coordinating Center

Steven H. Belle, PhD, MScHyg

Associate Professor of Epidemiology and 

Biostatistics

University of Pittsburgh

Epidemiology Data Center

127 Parran Hall

130 Desoto Street

Pittsburgh, PA 15261

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NIDDK Project Scientist

Carolyn W. Miles, PhD

Director, Clinical Obesity and Nutrition Program

Division of Digestive Diseases and Nutrition

NIDDK

NIH

6707 Democracy Blvd.

Room 665, MSC 5450

Bethesda, Maryland 20892-5450

For Further Information:

For additional assistance with media queries, including a list of LABS investigators with specific expertise

in topics related to bariatric surgery, contact: Ms.

Leslie L. Curtis, (301) 496-3585, NIDDK Office of

Communications and Public Liaison, (301) 496-

3583, curtisl@extra.niddk.nih.gov. For more information about LABS, see: www.niddklabs.org.

For general information about bariatric surgery,

obesity, and related topics, contact:

The Weight-control Information Network (WIN) 

1 WIN Way

Bethesda, Maryland 20892-3665

Phone: (202) 828-1025; Toll-free: 1-877-946-4627

www.win.niddk.nih.gov

The National Heart, Lung, and Blood Institute 

Information Center

P.O. Box 30105

Bethesda, Maryland 20824-0105

Phone: 1-800-575-9355

www.nhlbi.nih.gov 

For information about obesity research at NIH, see:

www.obesityresearch.nih.gov

To view general information about bariatric

surgery, see:

www.win.niddk.nih.gov/publications/gastric.htm

www.asbs.org (This site is not affiliated with the NIH.)

The National Institute of Diabetes and Digestive

and Kidney Diseases is part of the National

Institutes of Health, under the U.S. Department

of Health and Human Services.