(Directly incorporated from the application) The Washington Hospital Center/Medlantic Research Institute and the Howard University Medical School will collaborate in an effort to identify and enroll African Americans at risk for the development of IGT and NIDDM into a primary prevention trial. We will concentrate on recruitment of African Americans because of the disproportionate effect diabetes has on this community and the fact that Washington DC, with 70 percent African Americans, is estimated to have 52,000 citizens with diabetes, with half undiagnosed. The unique aspects of NIDDM in the African American population together with their disproportionate prevalence demand inclusion of African Americans as a major component of any primary prevention trial for NIDDM. Impaired glucose tolerance is the optimal time when interventions aimed at reversing the insulin resistance may prevent the progression of carbohydrate intolerance to NIDDM. We propose an efficient recruitment strategy based on the documented availability of groups enriched in the proportion of individuals with abnormal glucose tolerance. These include clinic patients seen at the Washington Hospital Center (WHC) and Howard University Hospital (HUH) who are obese and have relatives with NIDDM, patients with premature cardiovascular disease, and patients with a history of gestational diabetes. We propose a two by two factorial design to investigate aggressive lifestyle modification (diet and exercise), and pharmacologic intervention with metformin. Culturally appropriate interventions and follow-up techniques based on community support and input are presented designed to enhance retention and compliance. Primary endpoint determinations will be progression form IGT to NIDDM. Improvement of carbohydrate tolerance in newly diagnosed NIDDM will also be examined. Secondary end points include metabolic parameters related to insulin resistance, insulin secretion, lipoprotein changes and cardiovascular endpoints such as hypertension. Our center is experienced in the conduct of clinical trials and is committed to working with the Steering Committed in the design and conduct of the Trial.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK048387-08
Application #
6380902
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Garfield, Sanford A
Project Start
1994-08-20
Project End
2003-06-30
Budget Start
2001-07-01
Budget End
2002-06-30
Support Year
8
Fiscal Year
2001
Total Cost
$696,021
Indirect Cost
Name
Medstar Research Institute
Department
Type
DUNS #
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
Hivert, Marie-France; Christophi, Costas A; Franks, Paul W et al. (2016) Lifestyle and Metformin Ameliorate Insulin Sensitivity Independently of the Genetic Burden of Established Insulin Resistance Variants in Diabetes Prevention Program Participants. Diabetes 65:520-6
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

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