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临床试验/NCT00202241
NCT00202241已完成不适用

The Effects of Anabolic Steroids and Protease Inhibitors on Serum Blood Lipids,Muscle Mass, and Total Body Fat in People Living With HIV/AIDS

Queen's University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 1999年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
differences in serum lipid levels

研究概览

简要总结

The main aim of the study is to investigate the combined effects of using anabolic steroids and protease inhibitors on fat metabolism and body composition of People Living with HIV/AIDS.

We are seeking to answer the following questions:

1) Are there any significant differences in serum blood lipids, lipodystrophy, in persons with HIV taking antiretroviral therapies and anabolic steroids versus antiretroviral therapies alone?

详细描述

Changes in body composition and wasting have been a constant concern for people living with HIV/AIDS. Testosterone and its derivatives, anabolic steroids (AS) are being used by persons with HIV/AIDS (PHA's) to treat AIDs related wasting syndrome and also for bodybuilding purposes. some studies have shown that AS had a positive impact on the weight and well-being of HIV seropositive individuals.

It has been shown that protease inhibitors (PI's) in combination with other antiretroviral HIV therapies are associated with a symmetrical loss of subcutaneous fat from the body surface (lipodystrophy)in some PHAs.

The mechanism for lipodystrophy is not well understood. However, it is associated with hyperlipidemia that contributes to central fat deposition, insulin resistance, and in some, type 2 diabetes. As well, increased visceral abdominal fat and loss of fat inthe arms, legs and face, and increased levels of serum lipids have been reported.The health effects of anabolic steroid therapy coupled with PIs has not been examined before.

This study is an observational study investigating the phenomenon of lipodystrophy in an HIV population already exposed to AS and PIs. A prospective observational design will be employed, with two groups recruited. One group will be taking AS and PI's, the other will be taking PIs only.

The groups will be asked to completed Quality of Life nutrition and physical activity questionnaires. Serum blood lipid characteristics will be compared, and body composition will be determined using MRIs, BIA's and skinfold measurements.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • documented HIV seropositive status
  • 18 years of age or older
  • combination antiretroviral therapies for at least three months or more
  • able to comply with study procedures and protocol
  • signed informed consent

排除标准

  • acute opportunistic infections at baseline
  • use of serum lipid lowering drugs
  • use of serum sugar controlling drugs
  • evidence of drug or alcohol use which may interfere with study participation
  • a recent illness with associate weight loss of greater than or equal to 10lbs

结局指标

主要结局

differences in serum lipid levels

impacts on metabolic and cardiovascular health

differences in regional and overall body fat level

次要结局

  • quantity of muscle tissue between group comparison
  • comparison of 3 determinants of body composition(MRI,skinfold,BIA)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Wendy Wobeser

Principal Investigator

Queen's University

研究点 (2)

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