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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT00399360
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 and ≤ 65 years of age
* HIV positive, on a stable combination antiretroviral regimen for \> 6 months, including but not limited to either 2 nucleoside reverse transcriptase inhibitors (NRTI) and a non-nucleoside reverse transcriptase inhibitors (NNRTI) or protease inhibitor (PI), or a triple NRTI regimen
* Ability and motivation to modify behavior and make lifestyle changes
* NCEP-Adult Treatment Panel III defined metabolic syndrome, as defined by 3 out of 5 of the following: 1) Waist circumference greater than 102 cm (40 in) in men and 88 cm (35 in) in women, 2) Triglycerides ≥ 150 mg/dL or current anti-lipolytic drug treatment, 3) high-density lipoprotein less than 40mg/dL in men and 50 mg/dL in women, 4) Blood pressure ≥ 130/85 mmHg or current antihypertensive drug treatment, 5) Fasting glucose ≥ 100 mg/dL
Exclusion Criteria:
* Any new serious opportunistic infection within the past 6 weeks
* History of unstable angina, aortic stenosis, uncontrolled hypertension, severe neuropathy, arthritis or other contraindication to exercise
* Current therapy with insulin or other diabetic agent, fasting blood sugar \> 126
* Requiring parenteral nutrition or parenteral glucocorticoid therapy or oral glucocorticoid therapy
* Estrogen, progestational derivative, or ketoconazole use within 3 months
* New antiretroviral regimen in the past 6 months
* Serum creatinine \> 1.5 mg/dL (males) and 1.4 mg/dL (females), serum glutamic pyruvic transaminase-liver function (SGPT), \> 2.5 upper limit of normal (ULN), Lactate \> 2.0 ULN, hemoglobin \< 10.0 mg/dL
* Current substance and/or alcohol abuse
* Known hypersensitivity to Metformin
* Congestive heart failure requiring pharmacologic treatment
* Use of cimetidine or planned use during the study period
* Hypertrophic obstructive cardiomyopathy
* Pregnant or actively seeking pregnancy, breastfeeding
* Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for \< 3 months.
* Presence of active AIDS including cancers
* Current viral, bacterial or other infections (excluding HIV)
* Weight loss in the past 3 months of greater than 10 pounds
* Nitrates or other medications that can alter endothelial function
* Contraindication to beta blocker or nitroglycerin use
* Patients with previous allergic reactions to iodine-containing contrast media or to iodine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00399360
Study Brief:
Protocol Section:
NCT00399360