Lifestyle Modification and Metformin Use in the Treatment of HIV - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):	Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00399360

Purpose

A healthy diet and exercise have improved the health of people without 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.

Condition	Intervention
HIV Infections Metabolic Syndrome X	Drug: Metformin Drug: Placebo Behavioral: Lifestyle Modification

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Strategies for the Treatment of HIV Associated Metabolic Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Metabolic Syndrome

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Carotid Intima media thickness [ Time Frame: One year ] [ Designated as safety issue: No ]
Waist Circumference [ Time Frame: One year ] [ Designated as safety issue: No ]
Lipid levels [ Time Frame: one year ] [ Designated as safety issue: No ]
Glucose [ Time Frame: one year ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Inflammatory markers [ Time Frame: One Year ] [ Designated as safety issue: No ]
visceral adiposity [ Time Frame: One Year ] [ Designated as safety issue: No ]
cardiorespiratory fitness [ Time Frame: One Year ] [ Designated as safety issue: No ]
IMCL (exploratory) [ Time Frame: One Year ] [ Designated as safety issue: No ]
Coronary calcium score and stenosis (exploratory) [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2006
Estimated Study Completion Date:	June 2012
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Metformin and lifestyle modification	Drug: Metformin Starting at 500 Mg PO BID and increasing to 850 mg PO BID after 3 Months Behavioral: Lifestyle Modification Lifestyle Modification
Placebo Comparator: 2 Placebo and Lifestyle intervention	Drug: Placebo 500 mg PO BID Increasing to 850 mg PO BID After 3 Months Behavioral: Lifestyle Modification Lifestyle Modification
Placebo Comparator: 3 Placebo and No Lifestyle Modification	Drug: Placebo 500 mg PO BID Increasing to 850 mg PO BID After 3 Months
Active Comparator: 4 Metformin and No Lifestyle Intervention	Drug: Metformin Starting at 500 Mg PO BID and increasing to 850 mg PO BID after 3 Months

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Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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-ATP 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), SGPT, > 2.5 upper limit of normal, Lactate > 2.0 ULN, Hgb < 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399360

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Steven K. Grinspoon, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00399360 History of Changes
Other Study ID Numbers:	DK-49302-10AR, R01DK049302
Study First Received:	November 13, 2006
Last Updated:	October 6, 2011
Health Authority:	United States: Federal Government

Keywords provided by Massachusetts General Hospital:

HIV
Metabolic Syndrome
Lifestyle Modification
Metformin
Treatment Experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Metabolic Syndrome X
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes

Immune System Diseases
Slow Virus Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012