Status:
COMPLETED
Lifestyle Modification and Metformin Use in the Treatment of HIV
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV Infections
Metabolic Syndrome X
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A healthy diet and exercise have improved the health of people without human immunodeficiency virus (HIV) who have Metabolic Syndrome. In this study we would like to find out if the same benefit can b...
Detailed Description
After two initial screening visits with medical and nutrition staff for informed consent and determination of eligibility qualifying subjects will be seen for a baseline visit. At baseline subjects w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00399360
Start Date
December 1 2006
End Date
June 1 2012
Last Update
September 14 2012
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114