Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome

Brief Title

Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome

Official Title

Cellular Mechanisms for Metabolic Dysfunction in HIV

Brief Summary

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.

Study Phase

Phase 1

Study Type

Interventional

Condition

HIV Infections

Intervention

Avandia administration for 6-12 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Start Date

September 1999

Completion Date

August 2003

Eligibility 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

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Dr.Marie Gelato, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00006185

Organization ID

hivtzd (completed)

Secondary IDs

DK49316-06

Study Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor

Dr.Marie Gelato, Study Director, SUNY at Stony Brook

Verification Date

March 2010