Clinical trial NCT00027092: Use of a Test That Evaluates How the Body Handles Insulin and Glucose
Official title: AACTG Modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT) for the Assessment of Insulin Sensitivity: A Substudy of A5079
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Infusions, Intravenous
Testosterone
Insulin Resistance
Hormone Replacement Therapy
Glucose Tolerance Test
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-11-21
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are enrolled in A5079.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Univ of Southern California / LA County USC Med Ctr
state: California
city: San Francisco
country: United States
facility: Univ of California San Francisco
state: California
city: Honolulu
country: United States
facility: Univ of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hosp of Indiana / Life Care Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Wishard Hosp
state: Indiana
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
Study officials:
name: Shalender Bhasin
role: STUDY_CHAIR
References: