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NCT00340132 · ClinicalTrials.gov registry record

Cross-Sectional and Longitudinal Studies of "Pre-Diabetes" in the Pima Indians

A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
1,759
Enrollment target

NCT00340132: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00340132 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 1,759 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00340132 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
1,759 participants
Enrollment target

Study 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. \<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. ...

Primary Outcome

Measured via OGTT after ingestion of 75 grams of glucose over 2 minutes

Trial Details

FieldValue
Enrollment Target 1,759 participants
Start Date 1983-01-01

What the finished NCT00340132 record still lists

NCT00340132 is an observational study that tracks outcomes without assigning an intervention. Its 1,759 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 0 interventions.

NCT00340132 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00340132 about?

NCT00340132 is a clinical study titled "Cross-Sectional and Longitudinal Studies of "Pre-Diabetes" in the Pima Indians". 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 ...

What is the current status of trial NCT00340132?

This trial is currently completed. The enrollment target is 1,759 participants. The study started on 1983-01-01.

Who is sponsoring clinical trial NCT00340132?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00340132, the US trial registry maintained by the National Library of Medicine. NCT00340132 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.