HIV Infections Clinical Trial
Official title:
Cellular Mechanisms for Metabolic Dysfunction in HIV
With the advent of highly active anti-retroviral therapy(HAART), patients with HIV disease
are developing a series of metabolic abnormalities including peripheral fat wasting,
increase in truncal fat, high serum triglyceride levels, insulin(a hormone that controls
blood sugar) resistance with an increased incidence of Type 2 Diabetes Mellitus and elevated
blood pressure. The premise of this study is that abnormalities in the ability of fat and
muscle tissue to respond to the hormone insulin may be the cause of the diabetes mellitus,
high serum triglyceride levels and abnormal fat distribution. The purpose of the study is to
assess how insulin resistant patients with HIV disease are and if their fat and muscle
tissue are responding abnormally to insulin. This is done by administering insulin and
taking small tissue samples of fat and muscle from the upper thigh and assessing how good
insulin acts in these tissues.
Patients with HIV disease will be admitted into the study after undergoing a screening
medical history and examination. Once patients qualify, they will have their insulin
resistance measured as well as the response of their fat and muscle to insulin; blood levels
of glucose (sugar), cholesterol and triglycerides will be measured; body fat will be
assessed using radiological tests; a detailed medical history will be obtained to assess
risk factors for developing this syndrome.
Patients who are found to be insulin resistant will be offered a trial of an insulin
sensitizing agent, called Avandia, for 6-12 weeks. It is hoped that the Avandia will restore
the body's ability to respond normally to insulin (as it does in patients with Diabetes) and
perhaps improve the fat abnormalities as well. All the same measures will be performed at
the end of the course of Avandia as were done at baseline.
Patients who are not insulin resistant will be asked to come back yearly to assess whether
they develop insulin resistance over time. This study will continue to recruit patients over
the next 3 years.
n/a
Masking: Open Label, Primary Purpose: Diagnostic
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