Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027092
Status:
COMPLETED
Last Update Posted:
2008-08-07
First Post:
2001-11-20
Brief Title:
Use of a Test That Evaluates How the Body Handles Insulin and Glucose
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
AACTG Modified Frequently Sampled Intravenous Glucose Tolerance Test FSIVGTT for the Assessment of Insulin Sensitivity A Substudy of A5079
Status:
COMPLETED
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
Specific anti-HIV treatments may increase a patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5112s | None | None | None |