Evaluation of Skeletal Muscle Lipid Content by Magnetic Resonance Spectroscopy
| Tracking Information | |||||
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| First Received Date ICMJE | November 5, 2008 | ||||
| Last Updated Date | February 5, 2013 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
absolute change in intramyocellular lipid quantity with exercise [ Time Frame: over 4 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00786578 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 | Evaluation of Skeletal Muscle Lipid Content by Magnetic Resonance Spectroscopy | ||||
| Official Title ICMJE | Evaluation of Intramyocellular Lipid Content (IMCL) in Skeletal Muscle by Magnetic Resonance Spectroscopy | ||||
| Brief Summary | Type 2 diabetes is a growing public health issue and one component of Type 2 diabetes is 'insulin resistance" - the ability of insulin to work less well. The skeletal muscle is one of the largest users of sugar in the body, when the skeletal muscle is "insulin resistant", this contributes to diabetes. There is some evidence that the amount of fat in the skeletal muscle is related to the amount of insulin resistance. We are asking people to participate in a study to look at the amount of fat in muscle and how this fat amount changes with exercise. We hypothesize that heavier people will have higher amounts of fat and deplete this fat more slowly than lean subjects. |
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| Detailed Description | High intramyocellular lipid (IMCL) content in skeletal muscle has been correlated to insulin resistance in obese subjects. Yet, endurance athletes have high intramyocellular lipid content and very low insulin resistance. There are several explanations for this paradox. This study will use a new magnetic resonance imaging technique to look at the amount of fat in the muscle and its depletion with exercise. We hypothesize that overweight subjects will have higher amounts of fat and deplete this fat more slowly than lean subjects. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: blood will be sampled and retained for future metabolic testing as needed |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Healthy subjects on regular running program. |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 14 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | January 2014 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00786578 | ||||
| Other Study ID Numbers ICMJE | 0708M13941, 5K12RR023247-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Minnesota - Clinical and Translational Science Institute | ||||
| Study Sponsor ICMJE | University of Minnesota - Clinical and Translational Science Institute | ||||
| Collaborators ICMJE | National Center for Research Resources (NCRR) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Minnesota - Clinical and Translational Science Institute | ||||
| Verification Date | February 2013 | ||||
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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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