N/A N=50 Randomized Quadruple-blind Treatment

Lifestyle Modification and Metformin Use in the Treatment of HIV

HIV Infections · Metabolic Syndrome X

Bottom Line

View on ClinicalTrials.gov: NCT00399360 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Carotid Intima Media Thickness — -0.02; -0.02; 0.00; 0.03 mm — p=0.37

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Metformin (Drug); Placebo (Drug); Lifestyle Modification (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Carotid Intima Media Thickness	-0.02; -0.02; 0.00; 0.03	0.37
PRIMARY Waist Circumference	-1.9; -0.1; 0.3; -1.4	0.80
PRIMARY High Density Lipoprotein (HDL)	-2; 2; 0; 4	0.08
PRIMARY Glucose	-7; 3; 2; -7	0.13
PRIMARY Systolic Blood Pressure	-5; -2; -2; -6	0.85
PRIMARY Coronary Artery Calcium Score	43; 19; 1; -4	0.03 sig
SECONDARY C-reactive Protein	-0.27; -1.19; 0.47; -1.92	0.10
SECONDARY Abdominal Visceral Adiposity	-22.6; -1.5; -28.2; -35.0	0.63
SECONDARY Cardiorespiratory Fitness	-0.7; 2.0; -1.3; 3.7	0.05
SECONDARY Intramyocellular Lipid	0.6; -0.4; 0.8; 0.1	0.02 sig

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.

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

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Data sourced from ClinicalTrials.gov (NCT00399360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.