The Diabetes Prevention Program is a multicenter controlled clinical trialexamining the efficacy of an intensive life-style intervention or metformin toprevent or delay the development of diabetes in a population selected to be athigh risk due to the presence of impaired glucose tolerance (IGT). Developmentof diabetes, defined by 1997 ADA criteria, is the primary outcome whilecardiovascular disease and its risk factors are important secondary outcomes.The DPP began recruitment in mid-1996. At the time of this application, totalstudy exposure is a mean of approximately 3 years (range 2 to 5) with a totalof approximately 10,000 patient years in the 3,234 volunteers in the 3-armstudy. On the basis of a statistically significant and clinically compellingdecrease in the development of diabetes in the life-style intervention andmetformin-treated groups (58% and 31% reductions, respectively) compared withthe placebo treated group, the DPP Data Monitoring Board and NIDDK ended themasked treatment phase of the study in May, 2001, one year earlier thanoriginally planned.This application is designed to take further advantage of the scientificallyand clinically valuable cohort of DPP volunteers and the large volume of datacollected during the study. The highly compliant DPP cohort, including 45%minorities, is the largest IGT population ever studied. Moreover, the subcohortthat has developed diabetes (n approximately 700) has been followed from nearthe exact time of diabetes onset. Clinically important research questionsremain in the wake of the DPP. The carefully collected, centrally measured andgraded data in this cohort should help to answer, definitively, a number of important questions regarding the clinical course of IGT and early onset type 2diabetes.
Specific aims i nclude: 1. Examine the long-term effects anddurability of prior DPP intervention on the major DPP outcomes includingdiabetes, clinical cardiovascular disease, atherosclerosis, CVD risk factors,quality of life and cost-benefit; 2. Determine the clinical course of new onsettype 2 diabetes and IGT, in particular regarding microvascular and neurologiccomplications; 3. Determine the incidence of cardiovascular disease (CVD), CVDrisk factors and atherosclerosis in new onset type 2 diabetes and IGT; and 4.Examine topics 1-3 in minority populations, men vs. women, and in oldersubjects in the DPP. The current application is for 5 years of funding,although the some of the goals of the projects described will require a 10-yearstudy.
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