Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

Not Applicable

Completed

• Conditions: Insulin Resistance

• Registration Number: NCT00483392
• Lead Sponsor: University Medical Centre Ljubljana

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-06
• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-05
• Last Update Submitted: 2007-06-05
• Study First Posted: 2007-06-07
• Last Update Posted: 2007-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fasting plasma glucose, basal insulin levels	48 weeks

Secondary Outcome Measures

Name	Time	Method
insulin resistance, beta cell function	48 week

Trial Locations

Locations (1)

Department of Endocrinology, Diabetes and Metabolic diseases; 🇸🇮 Ljubljana, Slovenia