Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome
|ClinicalTrials.gov Identifier: NCT00006185|
Recruitment Status : Completed
First Posted : August 23, 2000
Last Update Posted : March 2, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Lipodystrophy Insulin Resistance||Drug: Avandia administration for 6-12 weeks||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Cellular Mechanisms for Metabolic Dysfunction in HIV|
|Study Start Date :||September 1999|
|Estimated Study Completion Date :||August 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006185
|United States, New York|
|University Hospital at Stony Brook New York|
|Stony Brook, New York, United States, 11794|
|Study Director:||Dr.Marie Gelato||SUNY at Stony Brook|