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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    Vanderbilt University Medical Center

    Nashville, Tennessee, United States, 37232