Exercise Dose Response for Improving Insulin Sensitivity
| Tracking Information | |||||
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| First Received Date ICMJE | October 11, 2011 | ||||
| Last Updated Date | December 14, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Insulin Sensitivity [ Time Frame: 2-3 hours ] [ Designated as safety issue: No ] A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity and will be performed using a primed 2h insulin infusion at a rate of 100 mU/m2/min. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01452035 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Exercise Dose Response for Improving Insulin Sensitivity | ||||
| Official Title ICMJE | Comparing the Effects Exercise Intensity and Energy Expended During a Single Exercise Session on Insulin Sensitivity and Fatty Acid Partitioning Within Skeletal Muscle the Next Day in Obese Adults. | ||||
| Brief Summary | Many of the beneficial metabolic effects of endurance exercise training are not due to adaptations to weeks, months, or even years of training, but rather much is due to the response to the most recent exercise session(s). Therefore, the investigators contend that lifestyle interventions for obese individuals should be tailored to optimize the metabolic effects of the most recent exercise session(s). But the "dose" of exercise necessary to evoke these beneficial responses is not known, and the mechanisms responsible for these improvements are poorly understood. The findings from these studies will: 1) establish the minimum "dose" of a single exercise session necessary to improve insulin sensitivity the next day in obese adults, 2) characterize the underlying metabolic factors responsible for the improvement in insulin sensitivity, and 3) assess the cumulative metabolic adaptations that occur over days, weeks, and months of a low-intensity/low-volume lifestyle exercise program. Findings from these studies will provide valuable information for the development of lifestyle programs aimed at maximizing the key metabolic health benefits of each exercise session in obese patients. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Other: Exercise
single session of exercise |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 18 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01452035 | ||||
| Other Study ID Numbers ICMJE | R01 DK077966 - MX, R01DK077966 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | JEFFREY F HOROWITZ, University of Michigan | ||||
| Study Sponsor ICMJE | University of Michigan | ||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||
| Verification Date | December 2012 | ||||
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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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