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Insulin Resistance Associated With Chronic Hepatitis C (CHC) and the Effect of Antiviral Therapy

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ClinicalTrials.gov Identifier: NCT00188240
Recruitment Status : Unknown
Verified September 2005 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : November 29, 2005
Sponsor:
Information provided by:
University Health Network, Toronto

Study Description
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Brief Summary:

The literature suggests that there may be an association between hepatitis C and type 2 diabetes mellitus independent of the presence of cirrhosis, the likely mechanism for which is insulin resistance. The prevalence of insulin resistance in patients with hepatitis C is unknown. Furthermore, there are no studies that indicate an increased prevalence of insulin resistance in patients with hepatitis C compared to other etiologies of liver disease. The role that hepatitis C may have in the development of insulin resistance is unclear. The effect of antiviral therapy for hepatitis C virus on insulin resistance has not been addressed. The long-term consequence of insulin resistance is type 2 diabetes mellitus. There is significant morbidity and mortality from type 2 diabetes mellitus in the general population, and similar complications would be expected in patients with hepatitis C and insulin resistance particularly if they develop type 2 diabetes mellitus.

Our hypothesis: The prevalence of insulin resistance is increased in patients with chronic hepatitis C compared to chronic hepatitis B. Secondarily, insulin resistance when present in patients with chronic hepatitis C improves with successful antiviral therapy.

This study has two phases. The first phase of our study will be to estimate the prevalence of insulin resistance in individuals with chronic hepatitis C without cirrhosis compared to patients with chronic hepatitis B without cirrhosis. The second phase of the study will be restricted to those patients with hepatitis C found to be insulin resistant from phase 1, in the absence of known risk factors for insulin resistance (cirrhosis, diabetes). The effect on insulin resistance of anti-viral therapy to eradicate hepatitis C will be assessed.


Condition or disease Intervention/treatment Phase
Hepatitis C Hepatitis B Drug: Pegasys; Copegus. Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insulin Resistance Associated With Chronic Hepatitis C (CHC) and the Effect of Anti-Viral Therapy
Study Start Date : August 2003

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Phase I - To evaluate the prevalence of insulin resistance in patients with hepatitis C without cirrhosis and compare it to that observed in patients with hepatitis B also without cirrhosis.
  2. Phase II - Interventional phase - To evaluate the effect of anti-viral therapy on insulin resistance, determined by the OGTT method, in patients with hepatitis C found to have insulin resistance pre-treatment.
  3. - To evaluate the safety, efficacy and tolerability of Pegasys (peginterferon alfa-2a) given in combination with Copegus (ribavirin) given for 24 weeks or 48 weeks in treatment naïve patients with chronic hepatitis C (CHC).

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada
  • Male and female patients
  • Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
  • Detectable serum HCV-RNA
  • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
  • All fertile males and females receiving Copegus must be using two forms of effective contraception during treatment and during the 6 months after treatment end
  • All patients should have insulin resistance (>2.1) determined by the homeostasis model assessment (HOMA) method.

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) < 6 months prior to the first dose of study drug
  • Any investigational drug < 6 weeks prior to the first dose of study drug
  • Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • Signs or symptoms of hepatocellular carcinoma
  • History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
  • Serum creatinine level >1.5 times the upper limit of normal at screening
  • History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
  • Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
  • Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study
  • Cirrhosis on liver biopsy
  • Type II diabetes mellitus
  • Diabetogenic medications including steroids
  • Current daily alcohol use of greater than 20 gm
  • Known hypersensitivity to any of the contents of the study drug
  • Patients currently participating in other Clinical Trials
  • Patients previously treated for hepatitis C / received alfa-interferon

Additional exclusion criteria for patients receiving Copegus:

  • Male partners of women who are pregnant
  • Hgb <12 g/dL in women or <13 g/dL in men at screening
  • Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
  • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with Copegus therapy) would not be well-tolerated
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188240


Contacts
Contact: Tharini Ganeshram 416-603-5839

Locations
Canada, Ontario
Liver Clinic, Toronto Western Hospital, UHN. Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: E.J.L. (Jenny) Heathcote, MD    416-603-5914      
Principal Investigator: E.J.L (Jenny) Heathcote, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: E.J.L (Jenny) Heathcote, MD UHN - Toronto Western Hospital, University of Toronto
More Information
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ClinicalTrials.gov Identifier: NCT00188240     History of Changes
Other Study ID Numbers: 03-0510-AE 04-0292-A
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 29, 2005
Last Verified: September 2005

Keywords provided by University Health Network, Toronto:
hepatitis C
insulin resistance
antiviral therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis B
Insulin Resistance
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs