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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00399360 |
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 |
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HIV Infections Metabolic Syndrome X |
Drug: Metformin Drug: Placebo Behavioral: Lifestyle Modification |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment |
Official Title: | Strategies for the Treatment of HIV Associated Metabolic Syndrome |
Estimated Enrollment: | 200 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Metformin and lifestyle modification
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Drug: Metformin
Starting at 500 Mg PO BID and increasing to 850 mg PO BID after 3 Months
Behavioral: Lifestyle Modification
Lifestyle Modification
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2: Placebo Comparator
Placebo and Lifestyle intervention
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Drug: Placebo
500 mg PO BID Increasing to 850 mg PO BID After 3 Months
Behavioral: Lifestyle Modification
Lifestyle Modification
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3: Placebo Comparator
Placebo and No Lifestyle Modification
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Drug: Placebo
500 mg PO BID Increasing to 850 mg PO BID After 3 Months
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4: Active Comparator
Metformin and No Lifestyle Intervention
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Drug: Metformin
Starting at 500 Mg PO BID and increasing to 850 mg PO BID after 3 Months
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathleen V Fitch, MSN, NP | 617-724-8015 | kfitch@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Steven K Grinspoon, MD 617-724-9109 | |
Contact: Steven K Grinspoon, MD 617 724-9109 | |
Principal Investigator: Steven K. Grinspoon, MD |
Principal Investigator: | Steven K. Grinspoon, MD | Massachusetts General Hospital |
Responsible Party: | MGH ( Steven Grinspoon, M.D. ) |
Study ID Numbers: | DK-49302-10AR |
Study First Received: | November 13, 2006 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00399360 History of Changes |
Health Authority: | United States: Federal Government |
HIV Metabolic Syndrome Lifestyle Modification Metformin Treatment Experienced |
Sexually Transmitted Diseases, Viral Metabolic Syndrome X Metabolic Diseases Metformin Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Abdominal Obesity Metabolic Syndrome Virus Diseases |
Hyperinsulinism Hypoglycemic Agents HIV Infections Sexually Transmitted Diseases Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Retroviridae Infections |
RNA Virus Infections Sexually Transmitted Diseases, Viral Metabolic Diseases Disease Slow Virus Diseases Metabolic Syndrome X Immune System Diseases Physiological Effects of Drugs Metformin Acquired Immunodeficiency Syndrome Infection Pharmacologic Actions |
Immunologic Deficiency Syndromes Virus Diseases Hyperinsulinism Hypoglycemic Agents Pathologic Processes HIV Infections Syndrome Sexually Transmitted Diseases Lentivirus Infections Insulin Resistance Glucose Metabolism Disorders Retroviridae Infections |