The Diabetes Prevention Program (DPP), a multi-center controlled clinical trial in a multiracial population of overweight persons with impaired glucose tolerance, established the efficacy of a life-style intervention aimed at a modest degree of weight loss and increased moderate-intensity activity, and of metformin in decreasing the development of diabetes by 58 and 31%, respectively. The DPP Outcome Study (DPPOS), a 10-year follow-up, was funded 1^2002 for a five-year period with the understanding that it would require refunding via competitive renewal. The overarching goal of DPPOS was to study whether the relatively shortterm benefits of delaying diabetes demonstrated in the DPP would translate into a more long-lasting impact that would reduce the public health burden of the diabetes epidemic. Specifically, DPPOS had the following major goals: 1) to determine the effects of DPP interventions on the long-term microvascular and cardiovascular disease (CVD) complications, atherosclerosis and CVD risk factors;2) to examine the long-term effects and durability of prior DPP interventions on further diabetes development;and 3) to describe the incidence of long-term complications and their risk factors in new onset type 2 diabetes and IGT. The DPPOS included an effort to maintain the original DPP metformin group on metformin and to continue a lifestyle intervention for the original lifestyle group. To date, after 10 years of DPP/DPPOS, 93% of the DPPOS cohort attends annual follow-up visits. A durable effect of diabetes prevention associated with the lifestyle and metformin interventions has been demonstrated with 36 and 19% reductions in diabetes incidence, respectively, compared with the placebo group. Interim analyses also reveal significant reductions in CVD risk factors in the intervention groups, with decreased utilization of medications. The development of diabetes is associated with an increased frequency of retinopathy and microalbuminuria. This application is designed to support completing the second five years of DPPOS focusing on complications that require more time to develop.

Public Health Relevance

The Diabetes Prevention Program (DPP) and first 5 years of the DPP Outcome Study (DPPOS) have demonstrated that a lifestyle intervention program aimed at weight loss, and metformin, prevent diabetes development over a 10 year period. Completion of DPPOS will examine the impact of diabetes prevention on long-term complications affecting the eye, kidney, nerves and heart, and remains critical to public health.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK048406-18
Application #
8034214
Study Section
Special Emphasis Panel (ZDK1-GRB-N (J1))
Program Officer
Linder, Barbara
Project Start
1994-08-15
Project End
2014-01-31
Budget Start
2011-02-01
Budget End
2012-01-31
Support Year
18
Fiscal Year
2011
Total Cost
$493,878
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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
Perreault, L; Pan, Q; Aroda, V R et al. (2017) Exploring residual risk for diabetes and microvascular disease in the Diabetes Prevention Program Outcomes Study (DPPOS). Diabet Med 34:1747-1755
Herman, William H; Pan, Qing; Edelstein, Sharon L et al. (2017) Impact of Lifestyle and Metformin Interventions on the Risk of Progression to Diabetes and Regression to Normal Glucose Regulation in Overweight or Obese People With Impaired Glucose Regulation. Diabetes Care 40:1668-1677
Goldberg, Ronald B; Temprosa, Marinella; Mele, Lisa et al. (2017) Erratum to: ""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 (2016) 65; 764-775]. Metabolism 68:184-186
Crandall, Jill P; Mather, Kieren; Rajpathak, Swapnil N et al. (2017) Statin use and risk of developing diabetes: results from the Diabetes Prevention Program. BMJ Open Diabetes Res Care 5:e000438
Goldberg, Ronald B; Aroda, Vanita R; Bluemke, David A et al. (2017) Effect of Long-Term Metformin and Lifestyle in the Diabetes Prevention Program and Its Outcome Study on Coronary Artery Calcium. Circulation 136:52-64
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
Zhou, Kaixin; Yee, Sook Wah; Seiser, Eric L et al. (2016) Variation in the glucose transporter gene SLC2A2 is associated with glycemic response to metformin. Nat Genet 48:1055-1059
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

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