Clinical trial NCT00853801: Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care
Official title: Detecting and Managing Metabolic Syndrome and Pre-Diabetes in General Medicine Clinic (Feasibility)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Diabetes
Metabolic Syndrome
Type 2 Diabetes
Keywords: Pre-Diabetes
Metabolic Syndrome
Type 2 Diabetes
Diabetes Prevention
Lifestyle Modification
Diet Therapy
Provider Education
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2009-03-02
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An educational intervention in the General Medicine Clinic aimed at both primary care providers (PCPs) and their patients with metabolic syndrome/pre-diabetes (MetSyn/PDM). Improving PCPs ability to detect and manage MetSyn/PDM, as measured by the increased incorporation of MetSyn/PDM into PCPs care plan, and increasing patients' awareness of healthy lifestyle behaviors results in positive patient health behaviors and outcomes.

Detailed description: The highest diabetes prevalence in the US is among African Americans (13.3%), American Indians (12.8%), and Mexican Americans (9.5%) with 8.7% of European Americans diagnosed with diabetes. In addition, certain minorities also have much higher rates of diabetes-related complications and death, in some instances by as much as 50% more than the general population, highlighting that the greatest need for preventive measures are amongst ethnic minorities.

The efficacy of lifestyle intervention in reducing the incidence of type 2 diabetes has been established by the Diabetes Prevention Program and other studies. The Cook County Bureau of Health Services, a publicly-funded healthcare system serving a primarily low-income, uninsured, ethnically diverse population in Chicago, IL, currently treats an estimated 40,000 patients annually for type 2 diabetes and estimates that another 85,000 to 100,000 patients are at risk for developing diabetes.

Our primary objective was to test the feasibility of integrating less intensive lifestyle intervention therapy into patient visits with their primary care provider to improve weight loss and decrease the intensity of metabolic syndrome and pre-diabetes risk factors. The site of the study is the General Medicine Clinic, a busy primary care outpatient site treating approximately 12,000 patients/year and 200 patients/day, staffed primarily by medical residents supervised by attending physicians.

Eligibility criteria: Inclusion Criteria:

* Has metabolic syndrome as defined by three or more of the five risk factors:

  * elevated blood pressure (BP) above 130 mm Hg systolic and/or 85 mm Hg diastolic or drug therapy for elevated blood pressure
  * elevated waist circumference (WC)above 35" (female) or above 40" (male)
  * reduced high-density lipoprotein (HDL) of below 40 mg/dl (male) or below 50 mg/dl (female) or drug therapy for reduced HDL
  * elevated triglycerides (TG) of 150 mg/dl or above or drug therapy for elevated TG
  * elevated fasting blood glucose (FBG) of 100 mg/dl and above and below 126 mg/dl)or pre-diabetes as defined as elevated FBG.
* Has a primary care provider in the General Medicine Clinic (GMC).

Exclusion Criteria:

* Has been diagnosed with any of the following:

  * diabetes
  * known CAD (MI, CABG, PTCA)
  * congestive Heart Failure NYHA Class III or IV
* Life expectancy less than 2 years
* Non-English speaking patient
* Patient whose physician is a PGY-3 resident, graduating before projected completion of the study

Primary outcomes:
measure: Patients adopt healthy lifestyle behaviors leading to significant weight loss, thus reducing their risk of diabetes and heart disease
timeFrame: 1.5 years
measure: Providers improve their ability to diagnose and treat metabolic syndrome/pre-diabetes.
timeFrame: 1.5 years
Secondary outcomes:
measure: Improve patient understanding of the metabolic syndrome/pre-diabetes risk parameters and the impact of healthy lifestyle changes on reducing their risk of developing heart disease and diabetes.
timeFrame: 1.5 years
measure: Create a model multidisciplinary team (physician, nurse, dietitian, health educator) to conduct group visits, lifestyle intervention education and follow-up of patients with metabolic syndrome/pre-diabetes.
timeFrame: 1.5 years
measure: Develop a system-wide database of patients with metabolic syndrome/pre-diabetes to target for preventive care.
timeFrame: 1.5 years
measure: Establish physician discussions and documentations encouraging lifestyle changes such as weight loss, healthy dietary changes and exercise.
timeFrame: 1.5 years
measure: Involve nursing staff in waist circumference measurement along with vital signs.
timeFrame: 1.5 years
measure: Assess changes in insulin resistance using the HOMA-IR index and in vascular inflammation status using C-Reactive protein in the intervention and control groups.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H Stroger Hospital
state: Illinois
Study officials:
affiliation: Cook County Health
name: Leon Fogelfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: