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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: | NCT00639457 |
The purpose is to examine the safety and efficacy of 16wks of pioglitazone (Actos; 30mg/d) with and without aerobic and strength exercise training for reducing glucose intolerance and central adiposity in HIV-infected people. We anticipate that pioglitazone + exercise training will improve glucose metabolism and insulin sensitivity, and reduce central adiposity more than pioglitazone alone. These improvements should translate into reduced cardiovascular disease risk in HIV-infected people.
Condition | Intervention |
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HIV Infections Type 2 Diabetes Obesity HIV AIDS Cardiovascular Disease Lipodystrophy |
Drug: Pioglitazone Other: Pioglitazone + exercise training |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Exercise and Pioglitazone for HIV-Metabolic Syndromes |
Estimated Enrollment: | 80 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Pioglitazone: Experimental
Pioglitazone (Actos; 30mg/day) for 16 weeks.
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Drug: Pioglitazone
Oral 30mg/day for 16 weeks
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Pioglitazone + Exercise training: Active Comparator
Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
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Other: Pioglitazone + exercise training
Oral 30mg/day for 16 weeks + Supervised aerobic and resistance exercise training (1.5hrs/day x 3 days/wk) for 16 weeks
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Our prior research has examined the pathogenesis and potential treatments for metabolic complications in people living with HIV. We have adopted the "lipotoxicity" hypothesis for Metabolic Syndrome X to explain the pathogenesis of impaired glucose tolerance (IGT) and fat redistribution in HIV: increased lipolysis and mobilization of lipids and free fatty acids from subcutaneous adipose depots leads to their excessive deposition in muscle and liver which contributes to dyslipidemia, insulin resistance, increased hepatic glucose output, and possibly visceral fat accumulation. Effective treatments have not been identified. Consensus groups recommend regular exercise and dietary modifications as primary and pharmacologic interventions as secondary treatments for the syndromes. We propose to test the efficacy of aerobic and weight lifting exercise training and an oral insulin-sensitizing agent (pioglitazone) as treatments for HIV-associated IGT and fat redistribution. We propose a 4-month, 2-group randomized study to evaluate the efficacy of pioglitazone and exercise + pioglitazone in 40 men and 40 women living with HIV and IGT and fat redistribution. We will measure: insulin sensitivity, glucose disposal rate, hepatic glucose production rate (5hr-hyperinsulinemic euglycemic clamp with 6,6-[2H2]-glucose); whole-body and regional fat and muscle content (1H-MRI of the abdomen and thigh & DEXA), soleus muscle and liver lipid content (1H-MRS), muscle and fat PPARgamma/alpha mRNA and protein expression, serum lipid profiles, and serum adiponectin levels before and at the end of 4 months of treatment. We hypothesize that exercise training + pioglitazone will be more effective than pioglitazone alone at improving insulin sensitivity, reducing visceral fat, liver and muscle lipid content, and increasing peripheral subcutaneous fat content in HIV-infected people. We hypothesize that combined treatment will be more effective because exercise training will activate PPARalpha expression in muscle and pioglitazone will activate PPARy expression in fat and muscle. We anticipate that this project will provide direct evidence that supports the combined use of exercise training and pioglitazone in people living with HIV and experiencing metabolic and anthropomorphic disorders that increase cardiovascular disease risk.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Kevin E Yarasheski, PhD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Kevin E. Yarasheski/Principal Investigator ) |
Study ID Numbers: | DK 049393, WU 157 |
Study First Received: | March 18, 2008 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00639457 |
Health Authority: | United States: Federal Government |
PPAR-gamma agonist glucose metabolism inflammation adipose tissue distribution |
cardiac function vascular function mass spectrometry Treatment Experienced |
Sexually Transmitted Diseases, Viral Pioglitazone Overweight Body Weight Signs and Symptoms Lipodystrophy Nutrition Disorders Retroviridae Infections Obesity Metabolic Diseases Skin Diseases Acquired Immunodeficiency Syndrome Diabetes Mellitus |
Endocrine System Diseases Immunologic Deficiency Syndromes Inflammation Virus Diseases HIV Infections Sexually Transmitted Diseases Diabetes Mellitus, Type 2 Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Lipid Metabolism Disorders |
RNA Virus Infections Hypoglycemic Agents Slow Virus Diseases Immune System Diseases Skin Diseases, Metabolic |
Physiological Effects of Drugs Lentivirus Infections Cardiovascular Diseases Infection Pharmacologic Actions |