Evaluation of Skeletal Muscle Lipid Content by Magnetic Resonance Spectroscopy - Full Text View

Sponsored by:	University of Minnesota
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00786578

Purpose

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.

Condition
Healthy Subjects

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

Drug Information available for: Insulin Lipids

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Evaluation of Intramyocellular Lipid Content (IMCL) in Skeletal Muscle by Magnetic Resonance Spectroscopy

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

absolute change in intramyocellular lipid quantity with exercise [ Time Frame: over 4 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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

Estimated Enrollment:	14
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 overweight runners (BMI>25)
2 lean runners (BMI<24)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy subjects on regular running program.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786578

Contacts

Contact: Lisa S Chow, MD

endores@umn.edu

Locations

United States, Minnesota
Univeresity of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator:

Lisa S Chow

University of Minnesota

More Information

Responsible Party:	University of Minnesota ( Lisa Chow MD )
Study ID Numbers:	0708M13941, 5K12RR023247-02
Study First Received:	November 5, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786578
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

training
intramyocellular lipid
insulin resistance

Study placed in the following topic categories:

Healthy
Insulin Resistance
Insulin

ClinicalTrials.gov processed this record on January 16, 2009