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Home > "U" Clinical Trials Conditions > Use of a Test that Evaluates How the Body Handles Insulin and Glucose  Use of a Test that Evaluates How the Body Handles Insulin and Glucose
Use of a Test that Evaluates How the Body Handles Insulin and Glucose
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to find out if testosterone gel affects how the body handles insulin and glucose. Specific anti-HIV treatments may increase a patient's risk of certain diseases by causing metabolic problems such as reduced sensitivity to insulin. This substudy will examine how testosterone affects insulin sensitivity. If testosterone increases insulin sensitivity in the patients, then giving testosterone to HIV-infected patients may allow the continuation of anti-HIV treatments without increasing the patients' risk of disease. The test used to determine insulin sensitivity will be a modified frequently sampled intravenous glucose tolerance test (FSIVGTT), which can accurately measure insulin sensitivity.
Details: Assessment of insulin sensitivity is an important objective of this substudy. Extrapolation from earlier studies suggests that insulin resistance will be associated with low testosterone levels at baseline in HIV-infected men with visceral obesity and that physiologic testosterone replacement in these individuals is likely to increase insulin sensitivity. However, direct assessment of insulin sensitivity under carefully controlled conditions is crucial to understanding the full metabolic impact of physiologic testosterone replacement in the context of A5079. The FSIVGTT, using the Bergman minimal model, has become a widely used method for the assessment of insulin sensitivity in epidemiological and intervention studies. Based on these considerations, the modified FSIVGTT was chosen as the optimal modality to assess insulin sensitivity in A5112s. This study is a substudy of A5079. Patients enrolled in A5079 are eligible for this substudy but receive no study treatment other than that which they receive on A5079. Insulin sensitivity is measured by FSIVGTT performed at entry and at Weeks 24 and 48. In the modified FSIVGTT, 15 serial blood specimens for glucose are drawn over a 245-minute interval. The FSIVGTT assesses whether patients given testosterone supplements have more sensitivity to insulin than patients given a placebo.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are enrolled in A5079.
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
ShalenderBhasin, Study Chair,
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Univ of California San Francisco
San Francisco, California, 94110
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Additional Information:
Study ID Numbers: ACTG A5112s; AACTG A5112s
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027092
Other Hiv Infections Studies:
1. A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
2. The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
3. Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
4. A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis carinii Pneumonia in Patients With AIDS Post First Episode PCP
5. A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients with HIV-Associated Kidney Disease
Related Studies:
Other HIV Infections Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Use of a Test that Evaluates How the Body Handles Insulin and Glucose
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