The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group

Diabetes Care. 2000 Nov;23(11):1619-29. doi: 10.2337/diacare.23.11.1619.

Abstract

Objective: The Diabetes Prevention Program (DPP) is a 27-center randomized clinical trial designed to evaluate the safety and efficacy of interventions that may delay or prevent development of diabetes in people at increased risk for type 2 diabetes.

Research design and methods: Eligibility requirements were age > or = 25 years, BMI > or = 24 kg/m2 (> or = 22 kg/m2 for Asian-Americans), and impaired glucose tolerance plus a fasting plasma glucose of 5.3-6.9 mmol/l (or < or = 6.9 mmol for American Indians). Randomization of participants into the DPP over 2.7 years ended in June 1999. Baseline data for the three treatment groups--intensive lifestyle modification, standard care plus metformin, and standard care plus placebo--are presented for the 3,234 participants who have been randomized.

Results: Of all participants, 55% were Caucasian, 20% were African-American, 16% were Hispanic, 5% were American Indian, and 4% were Asian-American. Their average age at entry was 51 +/- 10.7 years (mean +/- SD), and 67.7% were women. Moreover, 16% were < 40 years of age, and 20% were > or = 60 years of age. Of the women, 48% were postmenopausal. Men and women had similar frequencies of history of hypercholesterolemia (37 and 33%, respectively) or hypertension (29 and 26%, respectively). On the basis of fasting lipid determinations, 54% of men and 40% of women fit National Cholesterol Education Program criteria for abnormal lipid profiles. More men than women were current or former cigarette smokers or had a history of coronary heart disease. Furthermore, 66% of men and 71% of women had a first-degree relative with diabetes. Overall, BMI averaged 34.0 +/- 6.7 kg/m2 at baseline with 57% of the men and 73% of women having a BMI > or = 30 kg/m2. Average fasting plasma glucose (6.0 +/- 0.5 mmol/l) and HbA1c (5.9 +/- 0.5%) in men were comparable with values in women (5.9 +/- 0.4 mmol/l and 5.9 +/- 0.5%, respectively).

Conclusions: The DPP has successfully randomized a large cohort of participants with a wide distribution of age, obesity, and ethnic and racial backgrounds who are at high risk for developing type 2 diabetes. The study will examine the effects of interventions on the development of diabetes.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • African Americans
  • Asian Americans
  • Blood Glucose / metabolism
  • Blood Pressure
  • Body Mass Index
  • Cholesterol / blood
  • Cohort Studies
  • Continental Population Groups
  • Coronary Disease / epidemiology
  • Diabetes Mellitus, Type 2 / prevention & control*
  • European Continental Ancestry Group
  • Female
  • Glucose Intolerance / blood
  • Glucose Intolerance / diagnosis
  • Glucose Intolerance / rehabilitation*
  • Hispanic Americans
  • Humans
  • Hypercholesterolemia / epidemiology
  • Indians, North American
  • Lipids / blood
  • Male
  • Middle Aged
  • Patient Education as Topic*
  • Risk Factors
  • Sex Factors
  • Smoking / epidemiology
  • Socioeconomic Factors
  • United States

Substances

  • Blood Glucose
  • Lipids
  • Cholesterol