The objective of this multicenter clinical trial is to develop interventions to prevent the development of NIDDM in people with a history of gestational diabetes (GDM) and impaired glucose tolerance (IGT) (Cohort I primary prevention) and the worsening of glucose tolerance in people with newly diagnosed NIDDM with an FPG less than 140 mg/dl (Cohort II, secondary prevention). The central hypothesis of this application is that improvement of insulin resistance will delay the onset of NIDDM in individuals at risk. Therefore, we propose a five year randomized non-pharmacological and pharmacological factorial treatment design aimed to improve insulin resistance: Stratification will assure an overall trial representation of Black (0.4), Hispanic (0.2), Native American (0.2), GDM (0.2) and other races including Caucasian (1.0) Power calculations indicate that 20 centers contributing with 200 patients each will be necessary to fulfill the goal of the study. We will recruit the study subjects from among the Thomas Jefferson University employees. From a preliminary survey of the 7,294 full-time employees with a response rate of 58% revealed that 52% of the employees are at risk for NIDDM and that 76% have indicated interest in a NIDDM prevention trial, if available. It is hoped that the screening treatment follow-up and outcome measures methods will be translated to the society at large. To this end, it is important that both community and work-site models be developed.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
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Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Garfield, Sanford A
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Thomas Jefferson University
Internal Medicine/Medicine
Schools of Medicine
United States
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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
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
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

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