Insulin Resistance Clinical Trial
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 |
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 |
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.
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Slovenia | Department of Endocrinology, Diabetes and Metabolic diseases | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
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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