Insulin Resistance
Conditions
Keywords
insulin, rosiglitazone, metformin, hiv, protease inhibitors
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.
Interventions
DRUGmetformin, rosiglitazone
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fasting plasma glucose, basal insulin levels | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| insulin resistance, beta cell function | 48 week |
Countries
Slovenia
Outcome results
None listed