The application proposes to be a collaborating clinical center in the Non-insulin-dependent diabetes (NIDDM) Primary Trial. Working on a Steering Committee, we will help design the trial and Operations Manual in Year 01, implement it in Years 02-06, and close it in Year 07. The enormity of the NIDDM problem, rationale for primary prevention, and specific background are reviewed. Eligibility will be determined by the presence of impaired glucose tolerance, a history of gestational diabetes mellitus, or previously undiagnosed mild (FPG less than 140 mg/dl) NIDDM. Recruitment of more than 200 subjects randomized will be accomplished by proven methods of community screening and mailings, in large employment and population centers, targeting more than 50% African-American subjects. The trial will be implemented in an existing facility (Hopkins ProHealth) designed and staffed specifically for the implementation of large, multicenter, NIH-supported clinical trials. A faculty with wide diversity of expertise in clinical diabetes, epidemiology, behavioral change, exercise, diet and community intervention strategies and assessment will take part in study development and implementation; an expert staff is already in place at ProHealth, including a Study Coordinator, Recruiters, Interventionists and Data Collectors, will implement the study on a daily basis. Based on preliminary biostatistical considerations, a 3-arm trial is proposed, comparing intensive life style changes (diet and increased activity) with a pharmacologic arm (sulfinylureas) and a placebo are. The proposed primary outcome measure is incidence of NIDDM with FPG greater than 140 mg/dl; secondary outcome measures include a stepped deterioration of glucose tolerance, cardiovascular risk factors associated with NIDDM, quality of life measures, cost, and morbidity/mortality. Intervention strategies and visit schedules are outlined. Assuming a placebo-group event rate of 5% to 10% per year, two intervention groups will detect a 22% to 30% effect of interventions. In sum, this is a strong faculty and staff with extensive experience, an up-and-running clinical trials facility ready to take part in the collaborative effort of designing and implementing this primary prevention trial.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK048485-07
Application #
6177325
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Garfield, Sanford A
Project Start
1994-09-01
Project End
2003-06-30
Budget Start
2000-07-01
Budget End
2001-06-30
Support Year
7
Fiscal Year
2000
Total Cost
$780,741
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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
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
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

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