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 #
3U01DK048514-04S1
Application #
2834887
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Garfield, Sanford A
Project Start
1994-09-22
Project End
2001-06-30
Budget Start
1997-09-20
Budget End
1998-06-30
Support Year
4
Fiscal Year
1998
Total Cost
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
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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

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