An interventional study of testosterone injection in HIV, AIDS and Lipodystrophy, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-13.
Sponsored by Queen's University · Not applicable, Interventional, and Diagnostic
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:
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.
163 studies on the registry are indexed under Lipodystrophy; 11 are open to participants now.
This study's enrollment of 30 is below the median of 46 across 119 interventional studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
differences in serum lipid levels
differences in regional and overall body fat level
impacts on metabolic and cardiovascular health
quantity of muscle tissue between group comparison
comparison of 3 determinants of body composition(MRI,skinfold,BIA)
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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