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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center American Diabetes Association |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00362440 |
The purpose of this study is to determine whether patients with HIV lipodystrophy (fat wasting) benefit from taking the combination of two drugs, one insulin sensitizer (either metformin or pioglitazone, both diabetes drugs) and leptin (a natural hormone produced by your fat cells). Our hope is that they will improve sugar and fat metabolism and positively affect the body fat changes you have noticed while taking HAART.
Condition | Intervention | Phase |
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HIV Lipodystrophy |
Drug: Leptin Drug: Pioglitazone or metformin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
Estimated Enrollment: | 44 |
Study Start Date: | August 2006 |
Highly active antiretroviral therapy (HAART) induces profound and sustained suppression of human immunodeficiency virus (HIV) replication, and is thus very effective in reducing disease-associated morbidity and mortality in this patient population. However, HAART also results in the development of a lipodystrophic syndrome which is characterized by fat accumulation, fat wasting, or a combination of both, and similar to congenital forms of lipodystrophy, is associated with components of the metabolic syndrome, including insulin resistance (IR), fasting hypertriglyceridemia, and hypercholesterolemia.
Our study is a "proof of concept" study on the treatment of the HAART-induced metabolic syndrome, which builds upon and represents a direct extension of a study previously funded by the American Diabetes Association (ADA). If our clinical trial proves that a combination treatment of leptin and an insulin sensitizer has additive or synergistic effects in reversing the metabolic abnormalities of HIV positive patients with lipoatrophy, it could lead to the design of larger multi-center, randomized, placebo-controlled trial(s) aiming at establishing safety and efficacy of this treatment for the HAART-induced metabolic syndrome.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Decreased triceps skinfold thickness (< 4 mm in men and < 8 mm in women) or Decreased upper arm circumference (< 27.1 cm in men and < 23.3 cm in women) or Decreased subscapular skinfold thickness (< 7 mm in men and < 7 mm in women) or dual energy X-ray absorptiometry (DEXA) scanning suggestive of fat depletion: total body fat < 14% in men and < 22% in women.
Exclusion Criteria:
Contact: Christos Mantzoros, MD | 617-667-8628 | cmantzoros@bidmc.harvard.edu |
Contact: Aoife Brennan, MD | 617-667-8628 | abrenna1@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Sub-Investigator: Aoife Brennan, MD |
Principal Investigator: | Christos Mantzoros, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | 2005P-000159 |
Study First Received: | August 9, 2006 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00362440 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV lipodystrophy Leptin Fat wasting Pioglitazone Insulin resistance |
Hypoglycemic Agents Metabolic Diseases Pioglitazone Skin Diseases HIV Infections Metformin |
Lipodystrophy Acquired Immunodeficiency Syndrome Insulin Resistance Metabolic Disorder Insulin Lipid Metabolism Disorders |
Hypoglycemic Agents Metabolic Diseases Pioglitazone Skin Diseases Skin Diseases, Metabolic |
Physiological Effects of Drugs Lipodystrophy Pharmacologic Actions Lipid Metabolism Disorders |