The Diabetes Prevention Program is a multicenter controlled clinical trial examining the efficacy of an intensive life-style intervention or metformin to prevent or delay the development 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 approximately 3 years (range 2 to 5) with a total of approximately 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% 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 subcohort that has developed diabetes (n approximately 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 i nclude: 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 the some of the goals of the projects described will require a 10-year study.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK048387-13
Application #
7023098
Study Section
Special Emphasis Panel (ZDK1-GRB-D (J1))
Program Officer
Garfield, Sanford A
Project Start
1994-08-20
Project End
2009-01-31
Budget Start
2006-02-01
Budget End
2007-01-31
Support Year
13
Fiscal Year
2006
Total Cost
$491,792
Indirect Cost
Name
Medstar Research Institute
Department
Type
DUNS #
189030067
City
Hyattsville
State
MD
Country
United States
Zip Code
20782
de Groot, Mary; Marrero, David; Mele, Lisa et al. (2018) Depressive Symptoms, Antidepressant Medication Use, and Inflammatory Markers in the Diabetes Prevention Program. Psychosom Med 80:167-173
Kim, Catherine; Aroda, Vanita R; Goldberg, Ronald B et al. (2018) Androgens, Irregular Menses, and Risk of Diabetes and Coronary Artery Calcification in the Diabetes Prevention Program. J Clin Endocrinol Metab 103:486-496
Ceglia, Lisa; Nelson, Jason; Ware, James et al. (2017) Association between body weight and composition and plasma 25-hydroxyvitamin D level in the Diabetes Prevention Program. Eur J Nutr 56:161-170
McCaffery, Jeanne M; Jablonski, Kathleen A; Franks, Paul W et al. (2017) Replication of the Association of BDNF and MC4R Variants With Dietary Intake in the Diabetes Prevention Program. Psychosom Med 79:224-233
Kim, Catherine; Barrett-Connor, Elizabeth; Aroda, Vanita R et al. (2016) Testosterone and depressive symptoms among men in the Diabetes Prevention Program. Psychoneuroendocrinology 72:63-71
Walford, Geoffrey A; Ma, Yong; Clish, Clary et al. (2016) Metabolite Profiles of Diabetes Incidence and Intervention Response in the Diabetes Prevention Program. Diabetes 65:1424-33
Kim, C; Christophi, C A; Goldberg, R B et al. (2016) Adiponectin, C-reactive protein, fibrinogen and tissue plasminogen activator antigen levels among glucose-intolerant women with and without histories of gestational diabetes. Diabet Med 33:32-8
Aroda, Vanita R; Edelstein, Sharon L; Goldberg, Ronald B et al. (2016) Long-term Metformin Use and Vitamin B12 Deficiency in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab 101:1754-61
Goldberg, Ronald B; Temprosa, Marinella; Mele, Lisa et al. (2016) Change in adiponectin explains most of the change in HDL particles induced by lifestyle intervention but not metformin treatment in the Diabetes Prevention Program. Metabolism 65:764-75
Hall, Kathryn T; Jablonski, Kathleen A; Chen, Ling et al. (2016) Catechol-O-methyltransferase association with hemoglobin A1c. Metabolism 65:961-967

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