Study of Changes in Skeletal Muscle After Caloric Restriction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Charles R. Flynn, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00993460
First received: October 7, 2009
Last updated: February 21, 2014
Last verified: February 2014

October 7, 2009
February 21, 2014
March 2011
November 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
UPLC-ESI MS/MS profiling of lipd extracts from muscle biopsies to evaluate effects of short-term and long-term caloric restriction on diacylglycerol molecular species accumulation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00993460 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the effects of short-term and long-term caloric restriction on skeletal muscle insulin action via a hyperinsulinemic-euglycemic clamp and profiling markers of insulin signaling. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To evaluate the effects of short-term and long-term 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Changes in Skeletal Muscle After Caloric Restriction
Diacylglycerols and Insulin Action in Skeletal Muscle Upon Caloric Restriction

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, plasma, muscle tissue

Non-Probability Sample

Female subjects approved for Roux-en-Y gastric bypass surgery at Vanderbilt University Medical Center.

Obesity
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
November 2014
November 2013   (final data collection date for primary outcome measure)

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
Female
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00993460
IRB #091145
No
Charles R. Flynn, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Charles R Flynn, PhD Vanderbilt University
Study Chair: Naji Abumrad, MD Vanderbilt University
Vanderbilt University
February 2014

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