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
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