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Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution Clinical research trials and Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution. Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution clinical trial. Participants frequently obtain the most expert healthcare available for their Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution  Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution
Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution
For Condition: HIV Infections,Insulin Resistance
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , The Campbell Foundation
Synopsis: Several complications have become prevalent in people living with HIV/AIDS, including increased blood sugar, increased blood fats and cholesterol, and fat tissue redistribution. The causes of these complications are not well understood and effective treatments have not been identified. We propose to test the efficacy and safety of 2 treatments for these complications in people living with HIV/AIDS: aerobic, weight lifting exercise training, and a new insulin-sensitizing agent called rosiglitazone (Avandia). Exercise and rosiglitazone have been effective and moderately safe when used in HIV-seronegative people with diabetes, but a specific trial is needed to test efficacy and safety in people living with HIV/AIDS.
Details: We propose a 12wk controlled, randomized trial that compares the effects of rosiglitazone therapy, exercise training and combined rosiglitazone and exercise training. We hypothesize that rosiglitazone will lower blood sugar, insulin, blood fats, muscle and liver lipid content and composition in HIV-infected people. Exercise training will induce the same benefits, but will also reduce abdominal fat mass. We hypothesize that combining exercise training with rosiglitazone therapy will be most effective at reducing blood sugar, insulin, lipids, muscle and liver lipid contents, and restoring body fat distribution than either intervention alone. At baseline and after 12 wk of treatment we will measure: the ability of insulin to promote the clearance of sugar from the blood, the clearance rate of blood sugar, the rate of glucose production by the liver, blood fat and cholesterol concentrations, body fat content and fat distribution in the arms, legs, trunk regions, muscle and liver lipid content and composition.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: The research volunteers will consist of HIV-infected men and women treated with PI-based HAART who have developed insulin resistance of impaired glucose homeostasis: -fasting (8h) plasma glucose 110-126 mg/dL (6.1-7.1 mM) OR -plasma glucose >140 (7.8 mM) 2 hours after a 75g-oral glucose load. Although not required for enrollment, many of these volunteers will also have developed trunk adipose tissue redistribution (defined as): trunk/appendicular adipose ratio using whole-body DEXA >1.1 (men), >0.9 (women), or visceral adipose/total abdominal adipose tissue (VAT/TAT) >0.40 using 1H-MRI imaging at the level of the umbilicus (~L3-L4 inter-vertebral space). Many will also have developed fasting hypertriglyceridemia (>300mg/dL, >3.4 mM). -Plasma viremia (Roche Amplicor assay) <5000 copies/ml OR a CD4 T-cell county >= 200 cells/ul for at least 3 months prior to enrollment. -Stable on a PI-containing HAART regimen for at least 3 months prior to enrollment. -18-65 years of age -Body mass index <= 34kg/m*2, total body fat <=35% of weight
Total Enrollment:
Location and Contact Information:
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: NCRR-M01RR00036-0823;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025753
Other Hiv Infections Studies:
1. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine
2. A Study of WF 10 IV Solution in Patients with Advanced HIV Disease
3. The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined with MKC-442 in HIV-Infected Patients Who Have Not Had Success with Protease Inhibitors
4. Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
5. The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
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Rosiglitazone and exercise training: effects on HIV-infected people with insulin resistance, hypertriglyceridemia, and adipose tissue maldistribution
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