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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT01612858
Eligibility Criteria:
Inclusion Criteria:
* Age 18-70 years
* Fasting insulin \>12 μU/mL and/or serum glucose between 140-200 mg/dl after 75 g 2hr oral glucose tolerance test
* Central fat deposition or Peripheral fat atrophy
* Fasting glucose ≤126 mg/dL
* BMI ≥18 and ≤35 kg/m2
* CD4 cell count ≥100 cells/mm3
* Stable antiretroviral regimen ≥12 weeks and HIV RNA \<1000 copies
Exclusion Criteria:
* Diabetes mellitus
* Cardiac pacemaker or metal implant
* Liver enzymes \>2.5x upper normal limit
* Alkaline phosphatase or prothrombin time \>2x upper normal limit
* Serum creatinine \>1.4 mg/dL
* History of congestive heart failure
* Hemoglobin \<8 g/dL
* Alcohol abuse
* Pregnancy
* History of lactic acidosis
* Use of steroids
* Acute infection within last one month
* History of bladder cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01612858
Study Brief:
Protocol Section:
NCT01612858