Post DPP Follow Up Study: Data Coordinating Center

点击翻译按钮获取中文摘要

In this application, The Biostatistics Center of George Washington University proposes to serve as Coordinating Center for the Long-term Follow-up Study of the Diabetes Prevention Program cohort. This application differs from that of the clinical centers in that it presents descriptions of: Coordinating Center methods, DPP performance, and proposed central resources. The Diabetes Prevention Program is a multi-centercontrolled clinical trial examiningthe.efficacy of an intensive life- style intervention or metformin to prevent or delay the onset of diabetes in a population selected to be at high risk due to the presence of impaired glucose tolerance (IGT). Development of diabetes, defined by 1997 ADA criteria, is the primary outcome while cardiovascular disease and its risk factors are important secondary outcomes. The DPP began recruitment in mid-1996. At the time of this application, total study exposure is.a mean of ¿3.4years (range 2.4 to 5.4) with a total of-10,000 patient years in the 3,234 volunteers in the 3-arm study. On the basis of a statistically significant and clinically compelling decrease in the development of diabetes in the life-style intervention and metformin-treated groups. (58% and 31% risk reductions, respectively) compared with the placebo,treated group, the DPP Data Monitoring Board and NIDDK ended the masked treatment phase of the study in May, 2001, one year earlier than originally planned. This application is designed to take further advantage of the scientifically and clinically valuable cohort of DPP volunteers and the large volume of data collected during the study. The highly compliant DPP cohort, including 45% minorities, is the largest IGT population ever studied. Moreover, the sub-cohort that has developed diabetes (n¿700) has been followed from near the exact time of diabetes onset. Clinically important research questions remain in the wake of the DPP. The carefully collected, centrally measured and graded data in this cohort should help to answer, definitively, a number of important questions regarding the clinical course of IGT and early onset type 2 diabetes. Specific aims include: 1. Examine the long-term effects and durability of prior DPP intervention on the major DPP outcomes including diabetes, clinical cardiovascular disease, atherosclerosis, CVD risk factors, quality of life and cost-benefit; 2. Determine the clinical course of new onset type 2 diabetes and IGT, in particular regarding microvascular and neurologic complications; 3. .Determine the incidence of cardiovascular disease (CVD), CVD risk 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 older subjects in the DPP. The current application is for 5 years of funding, although some of the goals of the projects described will require a 10-year study.