Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome

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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