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NCT00410800 · ClinicalTrials.gov registry record
Insulin Secretory Defects in Pima Indians at High Risk for NIDDM
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 310
- Enrollment target
NCT00410800 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 310 participants.
The verdict
NCT00410800 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 310 participants
- Enrollment target
Study Summary
The Pima Indians have the highest reported prevalence of NIDDM of any population in the world. Within this population, it is possible to identify subgroups of individuals at a particularly high risk for NIDDM. This project examines whether defects in insulin secretion contribute to the higher risk of NIDDM in these subgroups and whether they progress over the course of the disease. Healthy Pima men and women at high risk for NIDDM including individuals in the following 3 groups will be recruited: 1)persons whose mothers and/or father developed diabetes at an early age (\< 35 y); 2) persons whose mothers were diabetic during pregnancy; and 3) persons whose birthweight was \< 2500 g. These individuals, as well as subjects with none of the above risk factors and a group of non-Pima controls, will be admitted to the NIH Clinical Research Unit at Phoenix Indian Medical Center for the following series of studies. Body composition will be determined by DXA scanning and by measuring the amount os visceral abdominal fat using MRI. A 75-g oral glucose tolerance test and a 25-g intravenous glucose tolerance test will be performed. Insulin action will be measured with a hyperinsulinemic-euglycemic glucose clamp (insulin infusion: 40mU/m(2) min and insulin secretory responses to glucose will be measured during a 5-step hyperglycemic glucose clamp immediately thereafter. Pima subjects will be followed longitudinally after discharge from the unit and oral glucose tolerance tests will be performed every three months. Individuals who transition from normal to impaired glucose tolerance or impaired glucose tolerance to diabetic will be invited back to the Clinical Research Center for repeat testing. By comparing insulin secretion-glucose dose-response curves, it may be possible to discern subtle defects in insulin secretion predisposing certain individuals to NIDDM. In addition, comparison of the responses in the offspring of diabetic pregnancies with those in the offspring of moth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 1996-08-19 |
| Est. Completion | 2011-08-16 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00410800
The ClinicalTrials.gov registry entry for NCT00410800 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00410800 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00410800 about?
NCT00410800 is a clinical study titled "Insulin Secretory Defects in Pima Indians at High Risk for NIDDM". The Pima Indians have the highest reported prevalence of NIDDM of any population in the world. Within this population, it is possible to identify subgroups of individuals at a particularly high risk for NIDDM. This project examines whether defects in insulin secretion contribute to the higher risk o...
What is the current status of trial NCT00410800?
This trial is currently completed. The enrollment target is 310 participants. The study started on 1996-08-19. Estimated completion is 2011-08-16.
Who is sponsoring clinical trial NCT00410800?
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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