Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
NCT00370617 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2006-11-14
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 severity of liver disease.
Insulin resistance seems to be genotype specific and may play a role in fibrogenesis in chronic hepatitis C.
In an "in vitro" model, increased levels of insulin may promote increased HCV replication.
RATIONALE Decreased insulin resistance and reduced hyperinsulinemia may facilitate the efficacy of anti-viral drugs on HCV replication.
Conditions
- Chronic Hepatitis C
- Insulin Resistance
Interventions
- DRUG
Sponsors & Collaborators
-
University of Turin, Italy
lead OTHER
Principal Investigators
-
Mario Rizzetto, MD · University of Torino
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-09-30
- Completion
- 2009-01-31
Countries
- Italy
Study Locations
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