Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
NCT ID: NCT00370617
Last Updated: 2006-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2006-09-30
2009-01-31
Brief Summary
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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.
Detailed Description
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* In patients with HCV infection, an increase in fasting insulin levels is associated with the presence of serum HCV core, the severity of hepatic fibrosis and a decrease in expression of insulin receptor substrate (IRS) 1 and IRS2, central molecules of the insulin-signaling cascade. Down-regulation of IRS1 and IRS2 has also been observed in HCV core-transgenic mice livers and HCV core-transfected human hepatoma cells.
* High levels of tumor necrosis factor-alpha, which acts by disturbing tyrosine phosphorylation of insulin receptor substrate-1, may be associated with insulin resistance both in animal models and in HCV patients.
Insulin resistance seems to be genotype specific and may play a role in fibrogenesis in chronic hepatitis C.
* In patients infected with genotype non-3, insulin resistance is associated with the degree of fibrosis, the rate of fibrosis progression and previous failed antiviral treatment.
* Insulin resistance, fibrosis, and genotype are independent predictors of the response to antiviral therapy in chronic hepatitis C patients treated with peginterferon plus ribavirin. A sustained virological response is achieved in 33% of patients with genotype 1 and insulin resistance compared with 60% of genotype 1 patients without insulin resistance.
* Insulin resistance is associated with a 3-fold risk of failure to antiviral treatment in patients with genotype 1 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.
INDICATION Genotype 1 Chronic HCV hepatitis (CHC) associated with insulin resistance (IR).
OBJECTIVES To compare the efficacy and safety of Pegylated-Interferon and Ribavirin plus metformin to Pegylated-Interferon and Ribavirin for treatment of naïve patients with Genotype 1 Chronic HCV infection and insulin resistance.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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metformin
Eligibility Criteria
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Inclusion Criteria
2. Persistently elevated alanine aminotransferase (ALT) and quantifiable HCV-RNA (\>2000 copies/ml)
3. Liver biopsy (within 12 months) consistent with CHC with or without cirrhosis
4. Compensated liver disease (Child-Pugh grade A)
5. Insulin resistance (evaluated by HOMA-R and OGTT)
6. Negative pregnancy test
Exclusion Criteria
2. BMI \> 30
3. Alcohol consumption \> 30 g/day
4. Other forms of liver disease (HBV, autoimmune, genetic), HIV infection.
5. Anemia
6. Psychiatric disease
7. Thyroid disease poorly controlled
8. Overt cirrhosis, hepatocellular carcinoma
9. Significant cardiac, renal, pulmonary disease, seizures.
18 Years
65 Years
ALL
No
Sponsors
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University of Turin, Italy
OTHER
Principal Investigators
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Mario Rizzetto, MD
Role: PRINCIPAL_INVESTIGATOR
University of Torino
Locations
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Division of Gastroenterology, University of Torino, Ospedale San Giovanni Battista
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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Mario Rizzetto, MD
Role: primary
Elisabetta Bugianesi, MD
Role: backup
References
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Romero-Gomez M, Del Mar Viloria M, Andrade RJ, Salmeron J, Diago M, Fernandez-Rodriguez CM, Corpas R, Cruz M, Grande L, Vazquez L, Munoz-De-Rueda P, Lopez-Serrano P, Gila A, Gutierrez ML, Perez C, Ruiz-Extremera A, Suarez E, Castillo J. Insulin resistance impairs sustained response rate to peginterferon plus ribavirin in chronic hepatitis C patients. Gastroenterology. 2005 Mar;128(3):636-41. doi: 10.1053/j.gastro.2004.12.049.
Other Identifiers
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METVIRAL
Identifier Type: -
Identifier Source: org_study_id