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NCT00483392 Clinical Trial

Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

Insulin Resistance Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00483392
Other study ID # J3-3545
Secondary ID Slovenia grant J
Status Completed
Phase N/A
First received June 5, 2007
Last updated June 5, 2007

Study information
Verified date June 2007
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority Slovenia: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and compare the effects of treatment with rosiglitazone and metformin on insulin resistance in patients infected with Human Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease Inhibitor after the period of 48 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- documented HIV infection

- stable Protease Inhibitor containing HAART regimen for at least 12 months

- impaired glucose tolerance

- elevated insulin levels (above 20 mIU/l)

Exclusion Criteria:

- patients already taking oral hypoglycaemic treatment or insulin

- heart failure NYHA I-IV

- liver disease or kidney disease

- elevated AST or ALT above 2 times upper normal range

- elevated creatinine (above 150 mmol/l)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• metformin, rosiglitazone

Locations
Country Name City State
Slovenia Department of Endocrinology, Diabetes and Metabolic diseases Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary fasting plasma glucose, basal insulin levels 48 weeks
Secondary insulin resistance, beta cell function 48 week
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