Cross-Sectional and Longitudinal Studies of 'Pre-Diabetes'

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 个研究点分布在 1 个国家目标入组 1,759 人2006年6月21日

概览

简要总结

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.

<TAB>

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.

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详细描述

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. \<TAB\> 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.

注册库

clinicaltrials.gov

开始日期

2006年6月21日

结束日期

待定

最后更新

昨天

研究类型

Observational

性别

All

研究者

发起方

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

责任方

Sponsor

入排标准

入选标准

•INCLUSION CRITERIA:
•Subjects from all racial and ethnic backgrounds will be invited to participate if they are:
•Ages: 18-55 years old (up to 2200 participants)
•Gender: male or female

排除标准

•Subjects will be excluded who are:
•Taking medication for a chronic illness.
•Have any acute or chronic diseases or conditions not specifically mentioned that in the opinion of the provider may interfere with the study or decrease safety for participation will be considered exclusionary.
•Women who currently pregnant or breastfeeding.
•Positive for drug and/or nicotine use.
•All medications and alcohol consumption are to be stopped for two weeks prior to admission. A urine drug-screening test for drugs such as narcotics, marijuana, and barbiturates will be performed on everyone to exclude from the study people whose urine show active or recent drug use. A positive drug test could confound the results of the study in an unpredictable manner. The results of this test will become a part of the patient s medical records and may be released if requested (please see page 6 of the consent for details regarding medical records release).