Status:
ACTIVE_NOT_RECRUITING
Study of Changes in Skeletal Muscle After Caloric Restriction
Lead Sponsor:
Vanderbilt University
Conditions:
Obesity
Eligibility:
FEMALE
21-65 years
Brief 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 su...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00993460
Start Date
March 1 2011
End Date
November 1 2026
Last Update
July 8 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232