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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: | NCT00656851 |
We hypothesize that the hearts of HIV+ people with The Metabolic Syndrome use and oxidize fats and sugars inappropriately, and that this may impair the heart's ability to pump blood. We hypothesize that exercise training or pioglitazone (Actos) will improve fat and sugar metabolism in the hearts of HIV+ people with The Metabolic Syndrome. This study will advance our understanding of cardiovascular disease in HIV+ people, and will test the efficacy of exercise training and pioglitazone for improving insulin resistance, heart metabolism and heart function in this at risk population.
Condition | Intervention |
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HIV Infections Cardiovascular Disease Insulin Resistance HIV Lipodystrophy The Metabolic Syndrome |
Drug: Pioglitazone Behavioral: Exercise Training |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Myocardial Function, Free Fatty Acid and Glucose Metabolism in HIV Metabolic Syndrome |
Estimated Enrollment: | 60 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Pioglitazone: Active Comparator
Pioglitazone (Actos, 30mg/day for 16 weeks)
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Drug: Pioglitazone
30mg/day for 16 weeks
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Exercise Training: Active Comparator
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
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Behavioral: Exercise Training
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
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We hypothesize that myocardial free fatty acid and glucose utilization and oxidation rates are dysregulated in HIV+ people with The Metabolic Syndrome in comparison to HIV+ people without The Metabolic Syndrome, and in comparison to HIV-seronegative people with and without The Metabolic Syndrome. We hypothesize that dysregulated myocardial fatty acid and glucose metabolism is associated with impaired heart function (diastolic dysfunction) in HIV+ people with The Metabolic Syndrome. We will use myocardial positron emission tomography, radioactive isotope tracers of palmitate and glucose, and echocardiography to evaluate myocardial metabolism and function. HIV+ people with The Metabolic Syndrome will receive 16wks of exercise training or pioglitazone (Actos), and we will evaluate their potential beneficial effects on myocardial metabolism and function.
Ages Eligible for Study: | 28 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: All participants both with and without metabolic syndrome:
Menstruating women must have a negative urine beta-HCG pregnancy test within 14 days prior to study. To control for potential metabolic effects of alterations in female hormones during the menstrual cycle, all menstruating women will be studied during the follicular phase (serum 17beta-estradiol <165 pg/mL).
Exclusion Criteria:
Contact: Sherry Lassa-Claxton, RD, MS | 314-362-7637 | slasscla@im.wustl.edu |
Contact: Todd Cade, PT, PhD | 314-286-1432 | tcade@wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Sherry Lassa-Claxton, RD, MS 314-362-7637 slasscla@im.wustl.edu | |
Contact: Todd Cade, PT, PhD 314-286-1432 tcade@wustl.edu | |
Sub-Investigator: Todd Cade, PT, PhD | |
Sub-Investigator: Robert Gropler, MD | |
Sub-Investigator: Victor Davila-Roman, MD | |
Principal Investigator: Kevin Yarasheski, PhD |
Principal Investigator: | Kevin Yarasheski, PhD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Kevin E. Yarasheski/Principal Investigator ) |
Study ID Numbers: | DK59531, HRPO 05-0976 |
Study First Received: | April 10, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00656851 |
Health Authority: | United States: Federal Government |
HIV/AIDS Heart disease Diabetes Cardiovascular disease risk |
Dyslipidemia Visceral adiposity treatment experienced |
Obesity Sexually Transmitted Diseases, Viral Metabolic Diseases Heart Diseases Pioglitazone Skin Diseases Acquired Immunodeficiency Syndrome Diabetes Mellitus Immunologic Deficiency Syndromes Virus Diseases |
Hyperinsulinism HIV Infections Lipodystrophy Sexually Transmitted Diseases Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Retroviridae Infections Dyslipidemias Lipid Metabolism Disorders |
RNA Virus Infections Slow Virus Diseases Disease Immune System Diseases Physiological Effects of Drugs Infection Pharmacologic Actions |
Pathologic Processes Hypoglycemic Agents Skin Diseases, Metabolic Syndrome Lentivirus Infections Cardiovascular Diseases |