Several factors are known to increase the risk of developing NIDDM, including a family history of diabetes, previous history of gestational diabetes (GDM), obesity, decreased physical activity, presence of impaired glucose tolerance (IGT) or insulin resistance. Moreover, the incidence of NIDDM is higher in several racial and ethnic minority groups in the US including African Americans, Hispanics, Native Americans, Native Alaskans, and Asian Americans. A five year multicenter trial is proposed to evaluate intervention strategies to prevent or delay the progression of IGT to NIDDM, or the progression of previously undiagnosed NIDDM with normal fasting glucose to fasting hyperglycemia. Within the context of the overall study design, the Joslin Diabetes Center, (JDC) South Cove Community Health Center (SCCHC) and Brigham and Women's Hospital (BWH) will collaborate to form a participating clinical center and will identify a cohort of 200 high risk patients (equal to approximately 100 patients with IGT or previously undiagnosed NIDDM and 100 obese women with a previous history of GDM) to be prospectively and randomly assigned to one of four intervention groups, comprising a 2 x 2 factorial design. Half of the patients will receive standard diet and exercise recommendations (standard group), while half will receive an intensive lifestyle modification program, including individualized dietary and exercise programs, instruction in behavioral change, stress reduction, smoking cessation and close follow up (intensive group). Within each group, half will be randomized to treatment with low dose sulfonylurea, and half will receive placebo. Volunteers will be screened and recruited from specifically identified high risk populations. These include first degree relatives of patients with NIDDM at the JDC, first degree relatives of patients with NIDDM at the SCCHC, first degree relatives of patients with NIDDM in the Harvard Community Health Plan and patients with a past history of obesity and GDM at BWH.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK048437-04S1
Application #
2834061
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
Joslin Diabetes Center
Department
Type
DUNS #
071723084
City
Boston
State
MA
Country
United States
Zip Code
02215
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
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
Mercader, Josep M; Liao, Rachel G; Bell, Avery D et al. (2017) A Loss-of-Function Splice Acceptor Variant in IGF2 Is Protective for Type 2 Diabetes. Diabetes 66:2903-2914
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
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

Showing the most recent 10 out of 29 publications