We propose a multi-center trial in which subjects would be screened for inclusion and exclusion criteria. A primary prevention subgroup will consist of subjects with impaired glucose tolerance (IGT) by National Diabetes Data Group (NDDG) criteria with a fasting plasma glucose (FPG) equal to or more than 110 mg/dl. A secondary intervention subgroup will consist of individuals with NIDDM by NDDG criteria and a FPG < 140 mg/dl. The subjects will been randomized in a 2 x 2 factorial design to: 1) intensive program of diet, exercise and stress reduction versus standard dietary and exercise advice as well as 2) therapy with either glipizide or placebo. We propose that the diet/exercise intervention be modeled after the PATHWAYS program (diet, exercise and stress management) which has been validated as an effective method of weight reduction in inner city African American women. Four thousand individuals would be followed at twenty centers to test whether these interventions can: l) prevent the worsening of glucose tolerance in these subjects over 5 years and 2) reduce cardiovascular morbidity and mortality. We believe our center is uniquely prepared to participate in both the design and execution of this major trial aimed at developing a program that can be easily translated into public health measures to reduce the epidemic of NIDDM and its consequent morbidity and mortality.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK048381-04S1
Application #
2834877
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Garfield, Sanford A
Project Start
1994-08-20
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 Chicago
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
225410919
City
Chicago
State
IL
Country
United States
Zip Code
60637
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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
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
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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