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Hepatitis C Infection With Liver Steatosis Compared to Hepatitis C Infection Without Liver Steatosis: Is There a Difference in Lipid Peroxidation and Indicators of Inflammation?

18 Years
Open (Enrolling)
Hepatitis C, Steatosis or no Steatosis

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Trial Information

Hepatitis C Infection With Liver Steatosis Compared to Hepatitis C Infection Without Liver Steatosis: Is There a Difference in Lipid Peroxidation and Indicators of Inflammation?

Hypothesis: Patients with Hepatitis C and steatosis are more oxidatively stressed than
those without steatosis. This is associated with 1) increased liver lipid peroxides and
cytokines (TNF-alpha, TGF-beta); 2) altered unsaturated fat status (intake, tissue storage
as measured in red blood cells); 3) reduced antioxidant status.

Objectives: To assess oxidative stress and nutritional status in patients with Hepatitis C
and steatosis on liver biopsy and to compare the results to the same parameters measured in
patients with Hepatitis C and no steatosis.


Primary outcome: Liver lipid peroxides

Secondary outcomes:

Liver: TNF-alpha; liver pathology and immunohistochemistry for adducts of MDA, a product of
lipid peroxidation (LP), alpha-smooth muscle actin (alpha-SMA), a marker of hepatic stellate
cell activation; and transforming growth factor (TGF-beta), a profibrogenic cytokine
involved in fibrogenesis, liver fatty acid composition (substrate for lipid peroxidation).

Oxidative stress and nutrition: Plasma lipid peroxides, plasma antioxidant vitamins,
antioxidant status and power, and red blood cell fatty acid composition, 7 day food record,

Other measurements:

Insulin resistance parameters such as blood glucose, insulin, c-peptide, HBA1c Blood lipid
profile, liver enzymes (as part of standard medical assessment) Subject demographics and
medical history will also be recorded.

Inclusion Criteria:

- Male and female patients, age >18 y

- Established hepatitis C infection as confirmed by positive serology and positive
hepatitis C RNA in serum

- Convincing evidence of negligible alcohol consumption (<20g of ethanol per day)
obtained from a detailed history, confirmed by at least one close relative

- Absence of any other possible cause for liver dysfunction.

- Undergoing routing liver biopsy (usually pre-treatment)

Exclusion Criteria:

- Findings highly suggestive of liver disease of other etiology (e.g. other viral
hepatitis, auto-immune chronic hepatitis, primary biliary cirrhosis and genetic liver
diseases such as hemochromatosis, alpha-1 antitrypsin deficiency, Wilsons disease
and biliary obstruction)

- Anticipated need for liver transplantation in one year or complications of liver
disease such as recurrent variceal bleeding, spontaneous porto- systemic
encephalopathy, resistant ascites or bacterial peritonitis

- Concurrent medical illnesses contraindicating a liver biopsy (history of unexplained
bleeding, hemophilia or abnormal coagulation results as per routine laboratory
work-up or other reasons judged by the hepatologist to contraindicate a percutaneous
liver biopsy)

- Medications known to precipitate steatohepatitis (corticosteroids, high dose
estrogens, methotrexate, amiodarone, calcium channel blockers, sulfasalazine or
cloxacillin) in the 6 months prior to entry

- Antioxidant vitamin or n-3 supplementation, ursodeoxycholic acid or any other
experimental drug in the 6 months prior to study entry

- Pregnant or lactating

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Principal Investigator

Johane P Allard, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto General Hospital


Canada: Ethics Review Committee

Study ID:

05-0305 AE



Start Date:

July 2005

Completion Date:

July 2010

Related Keywords:

  • Hepatitis C
  • Steatosis or no Steatosis
  • Hepatitis C
  • Steatosis
  • Oxidative Stress
  • Antioxidants
  • Inflammation
  • Fatty acids
  • Fatty Liver
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Inflammation
  • Hepatitis C, Chronic