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:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT01877551
Eligibility Criteria:
Inclusion Criteria:
* HIV+
* receiving protease inhibitor containing antiretroviral therapy for \>6 months
* Undetectable viral load
* insulin resistant
1. impaired fasting glucose (fasting blood glucose\>100mg/dl)
2. impaired glucose tolerance (blood glucose \>140mg/dl at 2 hours during oral glucose tolerance testing).
* abstained from medications that affect glucose (e.g. prednisone, growth hormone)
* stable medications for \>3 months
Exclusion Criteria:
* weight loss of \>5% of body weight in prior 6 months
* active gastrointestinal disease (gallstones, pancreatitis, hepatitis, diarrhea)
* use of anti-diabetic medications
* cardiovascular disease (uncontrolled hypertension, heart attack, heart failure, prior endocarditis)
* history of or active substance abuse
* blood clotting disorder or taking medications that affect blood clotting (e.g. coumadin, warfarin)
* pregnant, planning to become pregnant or lactating
* unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01877551
Study Brief:
Protocol Section:
NCT01877551