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

Abstract

A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. The Diabetes Prevention ProgramBaseline characteristics of the randomized cohort O R I G I N A L A R T I C L EOBJECTIVE -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 Ն25 years, BMI Ն24 kg/m 2 (Ն22 kg/m 2 for Asian-Americans), and impaired glucose tolerance plus a fasting plasma glucose of 5.3-6.9 mmol/l (or Յ6.9 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 Ͻ40 years of age, and 20% were Ն60 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 firstdegree relative with diabetes. Overall, BMI averaged 34.0 ± 6.7 kg/m 2 at baseline with 57% of the men and 73% of women having a BMI Ն30 kg/m 2 . Average fasting plasma glucose (6.0 ± 0.5 mmol/l) and HbA 1c (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.

GDF-15 as a Weight Watcher for Diabetic and Non-Diabetic People Treated With Metformin

“…Dysglycemia is strongly associated with the development of overweight status or obesity, as most DM2 patients are overweight or obese (44)(45)(46). For diabetic patients, managing overweight or obesity is a crucial facet of diabetes management.…”

Dynamic risk prediction for diabetes using biomarker change measurements

“…At baseline, more than one-third of participants had BMI greater than 35 kg/m 2 , and the majority did not smoke. Previous analyses have shown that these characteristics were balanced across the randomized treatment groups [40, 42]. Eight participants were missing HbA1c values at baseline and were thus excluded from our subsequent analyses.…”

Interaction Between Type 2 Diabetes Prevention Strategies and Genetic Determinants of Coronary Artery Disease on Cardiometabolic Risk Factors

“…The Diabetes Prevention Program Research Group conducted a multicenter randomized controlled trial in the U.S. that tested the effects of ILS and MET interventions on the incidence of diabetes in glucose-intolerant individuals as previously described in detail ( 16 , 17 ). In brief, a total of 3,234 participants with fasting plasma glucose levels between 5.3 and 6.9 mmol/L, and 2-h plasma glucose levels between 7.8 and 11.0 mmol/L during a standard 75-g oral glucose tolerance test, were randomized to ILS ( n = 1,079), MET (850 mg twice daily [ n = 1,073]), or placebo (PBO [ n = 1,082]).…”