- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00786578
Evaluation of Skeletal Muscle Lipid Content by Magnetic Resonance Spectroscopy
October 23, 2014 updated by: University of Minnesota
Evaluation of Intramyocellular Lipid Content (IMCL) in Skeletal Muscle by Magnetic Resonance Spectroscopy
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.
Study Overview
Status
Withdrawn
Conditions
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.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Univeresity of Minnesota
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy subjects on regular running program.
Description
Inclusion Criteria:
- Age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type.
- We will define the lean trained group by a BMI of < 24 kg/m2. We will define the overweight group as BMI > 26 25 kg/m2.
- The subjects should be participating in regular running exercise (> 30 min/day, ≥ 5 days/week).
- Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
Exclusion Criteria:
- The subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills, or diuretics.
- The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire.
- The subject must not have any contraindications to magnetic resonance imaging.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
overweight runners (BMI>25)
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2
lean runners (BMI<24)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
absolute change in intramyocellular lipid quantity with exercise
Time Frame: over 4 months
|
over 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa S Chow, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
January 1, 2014
Study Completion (ACTUAL)
January 1, 2014
Study Registration Dates
First Submitted
November 5, 2008
First Submitted That Met QC Criteria
November 5, 2008
First Posted (ESTIMATE)
November 6, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 24, 2014
Last Update Submitted That Met QC Criteria
October 23, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 0708M13941
- 5K12RR023247-02 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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