Lifestyle Modification and Metformin Use in the Treatment of HIV

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 be seen in people with HIV and Metabolic Syndrome. Patients with Metabolic Syndrome usually have a large waist, high blood cholesterol levels, high blood pressure, and high blood sugar levels. These are risk factors, which may increase one's chance of developing heart disease and/or diabetes. The purpose of the study is to evaluate the effects of different methods of treating HIV associated Metabolic Syndrome. The groups are: 1) a lifestyle modification program plus metformin (also known as glucophage), 2) lifestyle modification plus placebo, 3) metformin alone or 4) placebo alone. The lifestyle modification program consists of nutrition and exercise sessions with the goal of improving body composition, heart health, and ways to lower the risk of developing diabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Metformin

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