Use of a Test That Evaluates How the Body Handles Insulin and Glucose

HIV Infections Clinical Trial

Official title:

AACTG Modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT) for the Assessment of Insulin Sensitivity: A Substudy of A5079

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027092
• Other study ID #: ACTG A5112s
• Secondary ID: AACTG A5112s
• Status: Completed
• Phase: N/A
• First received: November 20, 2001
• Last updated: August 6, 2008

Study information

• Verified date: February 2004
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are enrolled in A5079.

Study Design

N/A

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Univ of Hawaii	Honolulu	Hawaii
United States	Indiana Univ Hosp	Indianapolis	Indiana
United States	Methodist Hosp of Indiana / Life Care Clinic	Indianapolis	Indiana
United States	Wishard Hosp	Indianapolis	Indiana
United States	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California
United States	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Univ of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

External Links

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