Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006185
First received: August 22, 2000
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
HIV Infections
Lipodystrophy
Insulin Resistance
Drug: Avandia administration for 6-12 weeks
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cellular Mechanisms for Metabolic Dysfunction in HIV

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: September 1999
Estimated Study Completion Date: August 2003
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006185

Locations
United States, New York
University Hospital at Stony Brook New York
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Investigators
Study Director: Dr.Marie Gelato SUNY at Stony Brook
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006185     History of Changes
Other Study ID Numbers: hivtzd (completed), DK49316-06
Study First Received: August 22, 2000
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
peripheral fat wasting
truncal adiposity
fat biopsy
muscle biopsy
intravenous lines
blood draws
insulin administration
sugar water
screening

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Insulin Resistance
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 18, 2014