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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00006185
Other study ID # hivtzd (completed)
Secondary ID DK49316-06
Status Completed
Phase Phase 1
First received August 22, 2000
Last updated March 1, 2010
Start date September 1999
Est. completion date August 2003

Study information

Verified date March 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
Avandia administration for 6-12 weeks


Locations

Country Name City State
United States University Hospital at Stony Brook New York Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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