Study of Changes in Skeletal Muscle After Caloric Restriction
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|ClinicalTrials.gov Identifier: NCT00993460|
Recruitment Status : Active, not recruiting
First Posted : October 12, 2009
Last Update Posted : April 4, 2018
|Condition or disease|
We hypothesize that in a setting of surgically-induced weight loss decrements in select DAGs result in improved glucose utilization, altered insulin signaling and decreased inflammatory responses. We propose to examine the impact of molecular DAG species accumulation on glucose utilization, insulin signaling and inflammation in skeletal muscle from morbidly obese subjects before/after 10% weight loss facilitated by Roux-en-Y Gastric Bypass (RYGB). We will compare these results to those from a control, normal weight cohort
The detected differences in DAG molecular species, insulin action, inflammatory responses between normal and obese subjects (before/after weight loss) will emphasize pathways coordinately altered as a consequence of adiposity and RYGB surgery. The primary endpoints for this study will be: Insulin sensitivity (glucose Rd, insulin levels, DAG mass, DAG species amounts).Secondary endpoints will be: FFA levels, inflammatory cytokine production, and insulin signaling in skeletal muscle.
|Study Type :||Observational|
|Estimated Enrollment :||24 participants|
|Official Title:||Diacylglycerols and Insulin Action in Skeletal Muscle Upon Caloric Restriction|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2019|
Normal body weight
Female subjects, ages 21-65 yrs, with BMI of 21-27 kg/m2 with normal glucose tolerance.
Roux-en-Y gastric bypass
Female subjects ages 21-65 with insulin resistance and scheduled for Roux-en-Y gastric bypass at Vanderbilt University Medical Center will be studied before and 4-6 weeks after surgery.
- 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. [ Time Frame: 1 year ]
- To evaluate the effects of gastric bypass induced-caloric restriction on skeletal muscle insulin action via a hyperinsulinemic-euglycemic clamp and profiling markers of insulin signaling. [ Time Frame: 1 year ]
- To evaluate the effects of gastric bypass induced-caloric restriction on lipid-mediated inflammatory responses by profiling cytokines and free fatty acids in blood and inflammation markers in skeletal muscle biopsies. [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993460
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Charles R Flynn, PhD||Vanderbilt University Medical Center|
|Study Chair:||Naji Abumrad, MD||Vanderbilt University Medical Center|