NCT00370617

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 14, 2006

Status Verified

November 1, 2006

First QC Date

August 30, 2006

Last Update Submit

November 13, 2006

Conditions

Chronic Hepatitis CInsulin Resistance

Keywords

chronic hepatitis Cinsulin resistancetherapy

Outcome Measures

Primary Outcomes (2)

  • Combined end-point of non-detectable serum HCV-RNA (<100 copies/mL) and

  • normal serum ALT activity at the end of the 24 week treatment-free follow up period

Secondary Outcomes (4)

  • End-of-treatment virological and biochemical response

  • Sustained virological and biochemical response

  • End-of-treatment improvement of insulin resistance

  • End-of-treatment improvement of liver histology

Interventions

metforminDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology, University of Torino, Ospedale San Giovanni Battista

Torino, 10126, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 15765399BACKGROUND

MeSH Terms

Conditions

Hepatitis C, ChronicInsulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Mario Rizzetto, MD

    University of Torino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Rizzetto, MD

CONTACT

+39-011-6336397mrizzetto@molinette.piemonte.it

Elisabetta Bugianesi, MD

CONTACT

+39-011-6336397ebugianesi@yahoo.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

September 1, 2006

Study Completion

January 1, 2009

Last Updated

November 14, 2006

Record last verified: 2006-11

Locations

IT(1)