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Underlying abnormalities in fat and muscle leading to Lipodystrophy Syndrome



Underlying abnormalities in fat and muscle leading to Lipodystrophy Syndrome

For Condition: Lipodystrophy,HIV Infections,Insulin Resistance
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Diagnostic, Open Label
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 18 years and older - Diagnosis of HIV or AIDS Exclusion Criteria: - Positive pregnancy test - Diagnosis of cancer - Acute illness (patients can be enrolled once stable) - Hemoglobin less than 7.0 g/dl or acute heart problems - Renal function greater than creatinine 1.5 mg/dl - Liver dysfunction 3 times normal - Use of medications like glucocorticoids and birth control pills - Untreated hypertension - Diabetes mellitus
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
Dr.MarieGelato,  Study Director,  SUNY at Stony Brook

University Hospital at Stony Brook New York
Stony Brook,  New York,  11794
United States
 


Additional Information:
Study ID Numbers:  hivtzd;  DK49316-06
Study Start Date: September 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006185

Other Hiv Infections Studies:
1. Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals

2. Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia

3. A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells

4. Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection

5. Prenatal and Postnatal Studies

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