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Life sciences · Observational Study
ClinicalTrials.gov · September 14, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT00340132). This is a study registration, not published results. Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 1759 participants (ACTUAL). Conditions: Weight Gain, Overweight, Insulin Resistance, Obesity, Diabetes Mellitus, Type 2. Primary outcome measures: Glucose tolerance via oral glucose tolerance test (OGTT) , Baseline, and after 180 minutes on day 4; Glucose tolerance via intravenous glucose tolerance test (IVGTT) , Baseline and after 10 minutes on day 5; Basal endogenous glucose production , Baseline, and after 100 minutes on day 10; 24-hour metabolic rate , Baseline and after 23.5 hours on day 7. Brief summary: Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus. A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes. These results suggest that both inherent (apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis) and acquired (evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin) defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes. To identify the genetic and environmental determinants of diabetes we are continuing to determine: (1) if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and (2) the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion. \ Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition, oral and intravenous glucose tolerance and in vivo insulin action. In addition, in selected subjects, adipose and/or skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues. A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies. Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity, insulin secretion, insulin resistance and/or type 2 diabetes.