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NCT00073268 · ClinicalTrials.gov registry record · Phase 1
Prevention of Type 2 Diabetes Mellitus in Children
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
NCT00073268 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 300 participants.
The verdict
NCT00073268, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
Study Summary
This is a pilot study to examine the short-term effects of supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children from a population that is at high risk for this disease. We hypothesize that exercise will significantly improve insulin sensitivity in all children, especially in children who are already insulin resistant, thereby lowering the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses being tested are: 1. Insulin resistance will be most evident in overweight children while an impaired ability of the pancreas to release insulin will be most evident in children with a family history of type 2 diabetes mellitus. 2. Exercise will significantly improve insulin resistance (as measured by the fasting glucose/insulin ratio) with little or no effect on insulin secretory capacity (as measured by circulating insulin concentration at 1, 3, and 5 minutes following an intravenous glucose load) in children. 3. Participation in a school-based health, nutrition, and exercise education program will have long-term beneficial effects on health-related behaviors and on insulin resistance.
Interventions
- BEHAVIORAL Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2002-12 |
| Est. Completion | 2007-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00073268
The ClinicalTrials.gov registry entry for NCT00073268 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 300 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 1 intervention - of which Exercise is the first listed.
NCT00073268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00073268 about?
NCT00073268 is a clinical study titled "Prevention of Type 2 Diabetes Mellitus in Children". This is a pilot study to examine the short-term effects of supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children from a population that is at high risk for this disease. We hypothesize that exercise will significantly improve insulin sensitivity in all children, espe...
What is the current status of trial NCT00073268?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2002-12. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00073268?
The interventions under investigation include: Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT00073268?
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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