As part of a multi-center grant we will attempt to prevent the development of NIDDM in 200 subjects with impaired glucose tolerance. The overall study will involve 20 clinical centers and 4000 subjects. This proposal will take seven years, with a one year protocol development, five year clinical trial and one year evaluation period. The proposed intervention will be a factorial design with one factor being diet and exercise versus usual cre and the second factor being an insulin sensitizer (e.g. Metformin) versus placebo. The primary endpoint will be the development of NIDDM. Secondary endpoints include changes in lipids, lipoproteins, ankle/arm ratio, urinary albumin and carotid wall thickness. Subjects will be obtained by several methods including: a) community advertising through radio and television advertisements; b) selective screening based on blood glucose from the Brady Green clinic; and c) subjects from the San Antonio Heart Study. Subjects identified with newly discovered diabetes but with normal fasting glycemia (2-hr glucose greater than or equal to 200 mg/dl, but fasting glucose <140 mg/dl) will be entered into a parallel secondary prevention trial to prevent the development of fasting hyperglycemia. In addition to the endpoints for the subjects in the primary prevention trial, these subjects will have assessment for diabetic neuropathy and retinopathy.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK048514-08
Application #
6380922
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Garfield, Sanford A
Project Start
1994-09-22
Project End
2003-06-30
Budget Start
2001-07-01
Budget End
2002-06-30
Support Year
8
Fiscal Year
2001
Total Cost
$691,141
Indirect Cost
Name
University of Texas Health Science Center San Antonio
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
800772162
City
San Antonio
State
TX
Country
United States
Zip Code
78229
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
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
Billings, Liana K; Jablonski, Kathleen A; Warner, A Sofia et al. (2017) Variation in Maturity-Onset Diabetes of the Young Genes Influence Response to Interventions for Diabetes Prevention. J Clin Endocrinol Metab 102:2678-2689
Aroda, Vanita R; Knowler, William C; Crandall, Jill P et al. (2017) Metformin for diabetes prevention: insights gained from the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study. Diabetologia 60:1601-1611
Rockette-Wagner, Bonny; Storti, Kristi L; Dabelea, Dana et al. (2017) Activity and Sedentary Time 10 Years After a Successful Lifestyle Intervention: The Diabetes Prevention Program. Am J Prev Med 52:292-299
Luchsinger, José A; Ma, Yong; Christophi, Costas A et al. (2017) Metformin, Lifestyle Intervention, and Cognition in the Diabetes Prevention Program Outcomes Study. Diabetes Care 40:958-965
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

Showing the most recent 10 out of 26 publications