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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 18, 2003 |
| Last Updated Date | December 6, 2007 |
| Start Date ICMJE | December 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00073268 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Prevention of Type 2 Diabetes Mellitus in Children |
| Official Title ICMJE | Prevention of Type 2 Diabetes Mellitus in Children |
| Brief 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:
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| Detailed Description | |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety Study |
| Condition ICMJE | Diabetes Mellitus, Type 2 |
| Intervention ICMJE | Behavioral: Exercise |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 300 |
| Completion Date | June 2007 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Early adolescent |
| Gender | Both |
| Ages | 12 Years to 15 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00073268 |
| Responsible Party | |
| Study ID Numbers ICMJE | 14239 |
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Verification Date | December 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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