Active — Not RecruitingNot Applicable

Study of Changes in Skeletal Muscle After Caloric Restriction

United States24 participantsStarted 2011-03

Plain-language summary

Research has shown that fat stored within muscles affects the muscle's sensitivity to insulin and ability to handle blood glucose. The purpose of this study is to examine the effects of weight loss surgery-induced caloric restriction on the accumulation and types of fats within skeletal muscle, as well as the effects of such caloric restriction on insulin sensitivity and inflammatory responses in skeletal muscle. The investigator proposes that caloric restriction will result in decreases in diacylglycerols enriched with saturated fat and increases in diacylglycerols enriched with monounsaturated fats.

Who can participate

Age range21 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * For Normal Weight Subjects: * Age 21-65 years * BMI of 21 to 27 kg/m2 * Normal glucose tolerance as determined by OGTT on day of screening * No family history of diabetes * For Morbidly Obese Subjects: * Age 21-65 years * BMI of 30 to 65 kg/m2 * Scheduled for Roux-en-Y gastric bypass at Vanderbilt Medical Center * Insulin resistant as determined by OGTT on day of screening Exclusion Criteria (for all subjects): * Clinically significant heart disease * Clinically significant hepatic or renal disease * Pregnancy * Breastfeeding * Any abnormality that would preclude safe completion of study * Use of statins * Use of thiazide or furosemide diuretics, beta blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless subject has been on stable dose of such medications for the past 3 months before entering the study

What they're measuring

UPLC-ESI MS/MS profiling of lipd extracts from muscle biopsies to evaluate effects of gastric bypass induced-caloric restriction on diacylglycerol molecular species accumulation.

Timeframe: 1 year

Trial details

NCT IDNCT00993460

SponsorVanderbilt University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-11