The principal goal of our randomized trial is to compare the efficacy of four different interventions, including conventional diet, conventional diet plus glipizide, conventional diet plus metformin, and a life style intervention with intensive diet and exercise, in preventing the progression of impaired glucose tolerance (IGT) to non-insulin dependent diabetes mellitus (NIDDM). Secondary goals include determining whether the interventions will affect the rate of reversion from IGT to normal glucose tolerance and/or improve cardiovascular risk factors, morbidity, or mortality. IGT prevails in 16% of the 40 to 74 year old U.S. population and is an appropriate target for intervention because IGT is l) a major risk factor for NIDDM which is difficult to treat effectively once it develops and is the cause of significant morbidity and mortality and 2), accompanied by numerous cardiovascular risk factors, morbidity and mortality. The proposal defines selection criteria for the IGT study population that will maximize the expected rate of conversion to NIDDM, empowering the study (75 to 93% power) to detect a 33 to 40% reduction in the hazard rate for development of NIDDM with intensive life-style intervention compared with the conventional diet. The selection criteria include screening for IGT subjects in populations with a high rate of recognized NIDDM (hispanic, black, and family members of NIDDM patients) and further selecting a subset of IGT subjects with a relatively high likelihood of progressing to NIDDM, i.e., obese IGT subjects with glucose levels equal to or greater than the median of the IGT range with OGTT. The experimental interventions have been selected based on 1) demonstrated salutary effects on glycemia and/or cardiovascular risk profile; 2) potential for practical application in the clinical setting;3) absence of frequent or severe side- effects. Investigators and subjects will be masked to treatment assignment except for the life-style intervention. Life-table analyses will be used to compare the cumulative incidences of the principal and secondary outcomes among the treatment groups. In addition, the absolute-level of chronic glycemia, selected lipid and insulin values, and blood pressure will be studied.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK048397-08
Application #
6380903
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
$956,277
Indirect Cost
Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199
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
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
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
Sylvetsky, Allison C; Edelstein, Sharon L; Walford, Geoffrey et al. (2017) A High-Carbohydrate, High-Fiber, Low-Fat Diet Results in Weight Loss among Adults at High Risk of Type 2 Diabetes. J Nutr 147:2060-2066
Kim, Catherine; Dabelea, Dana; Kalyani, Rita R et al. (2017) Changes in Visceral Adiposity, Subcutaneous Adiposity, and Sex Hormones in the Diabetes Prevention Program. J Clin Endocrinol Metab 102:3381-3389
Alzahrani, Saud; Nelson, Jason; Moss, Steven F et al. (2017) H. pylori seroprevalence and risk of diabetes: An ancillary case-control study nested in the diabetes prevention program. J Diabetes Complications 31:1515-1520
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

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