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

2008年8月6日更新者：National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

研究概览

地位

完全的

条件

艾滋病毒感染

详细说明

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.

研究类型

观察性的

注册

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- California
  - Los Angeles、California、美国、900331079
    - Univ of Southern California / LA County USC Med Ctr
  - San Francisco、California、美国、94110
    - Univ of California San Francisco
- Hawaii
  - Honolulu、Hawaii、美国、96816
    - Univ of Hawaii
- Illinois
  - Chicago、Illinois、美国、60612
    - Rush Presbyterian - Saint Luke's Med Ctr
- Indiana
  - Indianapolis、Indiana、美国、462025250
    - Indiana Univ Hosp
  - Indianapolis、Indiana、美国、46202
    - Methodist Hosp of Indiana / Life Care Clinic
  - Indianapolis、Indiana、美国、46202
    - Wishard Hosp
- New York
  - New York、New York、美国、10016
    - Bellevue Hosp / New York Univ Med Ctr

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria

Patients may be eligible for this study if they:

Are enrolled in A5079.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Institute of Allergy and Infectious Diseases (NIAID)

调查人员

学习椅：Shalender Bhasin

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究注册日期

首次提交

2001年11月20日

首先提交符合 QC 标准的

2001年11月20日

首次发布 (估计)

2001年11月21日

研究记录更新

最后更新发布 (估计)

2008年8月7日

上次提交的符合 QC 标准的更新

2008年8月6日

最后验证

2004年2月1日