Back to resultsTreatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
metformin, rosiglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring insulin, rosiglitazone, metformin, hiv, protease inhibitors
Eligibility Criteria
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)
Sites / Locations
- Department of Endocrinology, Diabetes and Metabolic diseases
Outcomes
Primary Outcome Measures
fasting plasma glucose, basal insulin levels
Secondary Outcome Measures
insulin resistance, beta cell function
Full Information
NCT ID
NCT00483392
First Posted
June 5, 2007
Last Updated
June 5, 2007
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT00483392
Brief Title
Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
insulin, rosiglitazone, metformin, hiv, protease inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
metformin, rosiglitazone
Primary Outcome Measure Information:
Title
fasting plasma glucose, basal insulin levels
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
insulin resistance, beta cell function
Time Frame
48 week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Janez, MD, PhD
Organizational Affiliation
Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Endocrinology, Diabetes and Metabolic diseases
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
18074413
Citation
Silic A, Janez A, Tomazic J, Karner P, Vidmar L, Sharma P, Maticic M. Effect of rosiglitazone and metformin on insulin resistance in patients infected with human immunodeficiency virus receiving highly active antiretroviral therapy containing protease inhibitor: randomized prospective controlled clinical trial. Croat Med J. 2007 Dec;48(6):791-9. doi: 10.3325/cmj.2007.6.791.
Results Reference
derived
Learn more about this trial
Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients
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