Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT00993460
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT00993460
Study Brief:
Protocol Section:
NCT00993460