Exercise in Insulin-Resistant Minority Adolescents
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ClinicalTrials.gov Identifier: NCT00345436 |
Recruitment Status
:
Completed
First Posted
: June 28, 2006
Last Update Posted
: July 2, 2017
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Tracking Information | |||
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First Submitted Date | June 27, 2006 | ||
First Posted Date | June 28, 2006 | ||
Last Update Posted Date | July 2, 2017 | ||
Study Start Date | February 8, 2006 | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures | Not Provided | ||
Original Primary Outcome Measures | Not Provided | ||
Change History | Complete list of historical versions of study NCT00345436 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures | Not Provided | ||
Original Secondary Outcome Measures | Not Provided | ||
Current Other Outcome Measures | Not Provided | ||
Original Other Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Exercise in Insulin-Resistant Minority Adolescents | ||
Official Title | 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 | Observational | ||
Study Design | Time Perspective: Prospective | ||
Target Follow-Up Duration | Not Provided | ||
Biospecimen | Not Provided | ||
Sampling Method | Not Provided | ||
Study Population | Not Provided | ||
Condition | Insulin-Resistance | ||
Intervention | 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 | Completed | ||
Estimated Enrollment |
40 | ||
Original Enrollment | Same as current | ||
Study Completion Date | May 11, 2011 | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria |
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 | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT00345436 | ||
Other Study ID Numbers | 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 | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||
Collaborators | Not Provided | ||
Investigators | Not Provided | ||
PRS Account | National Institutes of Health Clinical Center (CC) | ||
Verification Date | May 11, 2011 |