Hepatitis C Clinical Trial
Official title:
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?
Hepatitis C virus infection (HCV) is a major health concern in Canada and worldwide. Chronic
HCV can cause progressive liver damage leading to inflammation, scarring and, in some cases,
cirrhosis or liver cancer. It has been shown that fat accumulation in the liver can
accelerate the disease progression and is therefore a risk factor in HCV patients.
However, the exact mechanism(s) by which fat accumulation in the liver is involved in
disease progression are not clear yet. It is possible that the presence of fat provides a
liver susceptible to a second injurious process which leads to scarring. Candidates for this
second "hit" may include insulin resistance, leading to accumulation of fat within the liver
cells and secondly oxidation of these lipids. In turn, lipid peroxidation can lead to
production of reactive oxygen species (unstable molecules that can damage cells) and
cytokines (signal molecules that promote inflammation) resulting in more oxidative stress
and liver damage.
Aim of the study is to find out, whether patients with HCV and fatty liver have increased
oxidative stress and inflammation than patients with HCV without fatty liver, and whether
this is associated with a different nutritional status.
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.
Measurements:
Primary outcome: Liver lipid peroxides (LPO)
Secondary outcomes:
Liver: TNF-alpha; liver pathology and immunohistochemistry for adducts of malondialdehyde
(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,
anthropometry.
Other measurements:
Insulin resistance parameters such as blood glucose, insulin, c-peptide, hemoglobin A1c
(HbA1c) Blood lipid profile, liver enzymes (as part of standard medical assessment) Subject
demographics and medical history will also be recorded.
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Observational Model: Case-Only, Time Perspective: Cross-Sectional
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