Insulin Secretory Defects in Pima Indians at High Risk for NIDDM
Public ClinicalTrials.gov record NCT00410800. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 mothers who subsequently became diabetic may allow us to separate defects due to genetic causes from those due to the intrauterine environment. Finally, studying subjects as they progress from normal glucose tolerance to diabetes will test whether the defects in insulin secretion are progressive and contribute to the development of NIDDM.
Study identification
- NCT ID
- NCT00410800
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 310 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 18, 1996
- Primary completion
- Not listed
- Completion
- Aug 15, 2011
- Last update posted
- Jul 1, 2017
1996 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NIDDK, Phoenix | Phoenix | Arizona | 85014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00410800, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00410800 live on ClinicalTrials.gov.