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Exercise in Insulin-Resistant Minority Adolescents
This study has been completed.
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00345436
First received: June 27, 2006
Last updated: June 30, 2017
Last verified: May 11, 2011
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | June 27, 2006 | ||
| Last Updated Date | June 30, 2017 | ||
| Start Date ICMJE | February 8, 2006 | ||
| Primary Completion Date | Not Provided | ||
| Current Primary Outcome Measures ICMJE | Not Provided | ||
| Original Primary Outcome Measures ICMJE | Not Provided | ||
| Change History | Complete list of historical versions of study NCT00345436 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Exercise in Insulin-Resistant Minority Adolescents | ||
| Official Title ICMJE | An Exercise Intervention in Insulin-Resistant Minority Adolescents | ||
| Brief Summary | Insulin resistance, often accompanied by obesity, plays a major role in the development of type 2 diabetes. This phenomenon may be related with the fact that American adolescents are now becoming less physically active in early puberty, explaining the largely pubertal and post-pubertal onset of type 2 diabetes in adolescence. Although regular physical activity has been suggested to attenuate obesity and prevent type 2 diabetes in high-risk children and adolescents, the magnitude of exercise training-induced improvement in the risk factors for type 2 diabetes has been only recently studied in adults and studied very little in pediatric populations. It is clear that exercise, diet, and genetics all contribute to the development of type 2 diabetes in children. However, the few studies that have been done to dissect the relative contributions of these three risk factors have generally used only lipid profiles as the end point. There have been a number of recent advances in our understanding of the molecular basis of type 2 diabetes, particularly, with regards to insulin regulatory pathways modulated by exercise within muscle tissue. | ||
| Detailed Description | Insulin resistance, often accompanied by obesity, plays a major role in the development of type 2 diabetes. This phenomenon may be related with the fact that American adolescents are now becoming less physically active in early puberty, explaining the largely pubertal and post-pubertal onset of type 2 diabetes in adolescence. Although regular physical activity has been suggested to attenuate obesity and prevent type 2 diabetes in high-risk children and adolescents, the magnitude of exercise training-induced improvement in the risk factors for type 2 diabetes has been only recently studied in adults and studied very little in pediatric populations. It is clear that exercise, diet, and genetics all contribute to the development of type 2 diabetes in children. However, the few studies that have been done to dissect the relative contributions of these three risk factors have generally used only lipid profiles as the end point. There have been a number of recent advances in our understanding of the molecular basis of type 2 diabetes, particularly, with regards to insulin regulatory pathways modulated by exercise within muscle tissue. | ||
| Study Type ICMJE | Observational | ||
| Study Design ICMJE | Time Perspective: Prospective | ||
| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Not Provided | ||
| Study Population | Not Provided | ||
| Condition ICMJE | Insulin-Resistance | ||
| Intervention ICMJE | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Estimated Enrollment ICMJE | 40 | ||
| Estimated Completion Date | May 11, 2011 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE |
To be included in this study, subjects must meet the following conditions: Sedentary (regular aerobic exercise less than or equal to 2 times/wk and less than 20 min/session): nonsmoker; impaired glucose tolerance (fasting plasma glucose greater than or equal to 100 mg/dl but less than 126 mg/dl or/and 2 hour plasma glucose greater than or equal to 140 mg/dl but less than 200 MG/dl; BMI-for-age is 95% or greater. EXCLUSION CRITERIA: Not pregnant; and not have any other medical condition that would preclude regular exercise. If taking medication known to affect metabolism. History of chronic illness known to affect metabolism. |
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| Sex/Gender |
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| Ages | 14 Years to 18 Years (Child, Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00345436 | ||
| Other Study ID Numbers ICMJE | 999906094 06-CH-N094 |
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| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | National Institutes of Health Clinical Center (CC) | ||
| Verification Date | May 11, 2011 | ||
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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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