Evaluation of Skeletal Muscle Lipid Content by Magnetic Resonance Spectroscopy

This study has been withdrawn prior to enrollment.
(not funded)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00786578
First received: November 5, 2008
Last updated: October 23, 2014
Last verified: October 2014

November 5, 2008
October 23, 2014
January 2010
January 2014   (final data collection date for primary outcome measure)
absolute change in intramyocellular lipid quantity with exercise [ Time Frame: over 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00786578 on ClinicalTrials.gov Archive Site
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Evaluation of Skeletal Muscle Lipid Content by Magnetic Resonance Spectroscopy
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood will be sampled and retained for future metabolic testing as needed

Non-Probability Sample

Healthy subjects on regular running program.

Healthy
Not Provided
  • 1
    overweight runners (BMI>25)
  • 2
    lean runners (BMI<24)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00786578
0708M13941, 5K12RR023247-02
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Center for Research Resources (NCRR)
Principal Investigator: Lisa S Chow University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP