Status:
UNKNOWN
Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
Lead Sponsor:
University of Turin, Italy
Conditions:
Chronic Hepatitis C
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Chronic hepatitis C virus (HCV) infection is associated with an increased risk for the development of type 2 diabetes and HCV infection itself may promote insulin resistance, irrespective of the sever...
Detailed Description
Chronic hepatitis C virus (HCV) infection is associated with an increased risk for the development of type 2 diabetes and HCV infection itself may promote insulin resistance, irrespective of the sever...
Eligibility Criteria
Inclusion
- No previous antiviral treatment
- Persistently elevated alanine aminotransferase (ALT) and quantifiable HCV-RNA (\>2000 copies/ml)
- Liver biopsy (within 12 months) consistent with CHC with or without cirrhosis
- Compensated liver disease (Child-Pugh grade A)
- Insulin resistance (evaluated by HOMA-R and OGTT)
- Negative pregnancy test
Exclusion
- Type 2 Diabetes (according to ADA criteria)
- BMI \> 30
- Alcohol consumption \> 30 g/day
- Other forms of liver disease (HBV, autoimmune, genetic), HIV infection.
- Anemia
- Psychiatric disease
- Thyroid disease poorly controlled
- Overt cirrhosis, hepatocellular carcinoma
- Significant cardiac, renal, pulmonary disease, seizures.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00370617
Start Date
September 1 2006
End Date
January 1 2009
Last Update
November 14 2006
Active Locations (1)
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1
Division of Gastroenterology, University of Torino, Ospedale San Giovanni Battista
Torino, Italy, 10126