Prospective Clinical Study of the Role of the Immune Response, in Relation to Diet, in Patients Affected by Either Chronic Hepatitis C Virus (HCV) Infection or Non Alcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT02038387

Last Updated: 2014-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31

Brief Summary

Chronic hepatitis C virus (HCV) infection and nonalcoholic fatty liver disease (NAFLD) are characterized by a spectrum of pathological conditions ranging from an early stage of inflammation and fibrosis up to more advanced disease conditions, such as hepatocellular carcinoma. The prevalence of NAFLD is between 10 and 25% of the population, with large differences in age and ethnic groups, while it is well known that HCV infection is a major cause of chronic liver disease in Western countries.

For both diseases the progression of liver damage is in close correlation with the lifestyle of patients (eg., nutrition, physical activity, ingestion of alcohol, etc.). In fact, it was shown that feeding imbalances may have implications in altering the normal immune functions of the subjects, suggesting that the metabolic and the immune systems are closely related to each other. Although it is well known the negative role of obesity on the progression of NAFLD and HCV liver diseases, the pathogenic mechanism underlying the alterations related to the immune response is not yet fully understood. Insulin resistance, altered lipid metabolism, lipid peroxidation, oxidative stress and mitochondrial alterations are pathogenic mechanisms that induce liver damage and its progression, both in NAFLD and in HCV infection.

Recent studies suggest that the evolution of viral infections and chronic inflammation in NAFLD are deeply influenced by CD4+ T helper cells expressing IL-17 , defined as T helper 17 (Th17) cells. Broadening the knowledge on the role of diet in the course of NAFLD and HCV infection in the activation of Th17 cells and in the alteration of some of their functions, will allow to shed light on the pathogenic mechanisms underlying the progression of immune-mediated diseases. Moreover, this investigation will allow to understand whether Th17 cells may have a role in the diminished response to therapy in patients who have high cholesterol levels.

If the results will confirm our hypothesis, this study will provide useful informations for the clinical management of patients with both steatosis and chronic HCV infection. The data obtained can also be used for the development of new therapeutic strategies directed to modulate the antiviral immune response.

All patients will undergo clinical and instrumental assessment depending on the type of pathology. Patients will be required to follow a normocaloric low cholesterol diet for a period of 30 days.

The prospective clinical study does not present any form of additional risk for the patients and will be conducted in accordance with the principles established by the Declaration of Helsinki and with the standards of Good Clinical Practice (GCP). The study does not require any additional costs.

Conditions

Chronic Hepatitis C Virus; Non Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diet

Group Type: EXPERIMENTAL

normocaloric low cholesterol diet

Intervention Type: BEHAVIORAL

Interventions

normocaloric low cholesterol diet

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• chronic HCV infection or NAFLD

Exclusion Criteria

• any pharmacological treatment at least 6 months before entering the study, liver cirrhosis, co-infection by hepatitis B virus, or human immunodeficiency virus infections, autoimmune diseases, and other relevant associated-diseases such as decompensated diabetes, kidney diseases, pulmonary diseases, tumors.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Prof. Clara Balsano

Prospective clinical study on the role of the immune response, in relation to diet, in patients affected by either chronic hepatitis C virus (HCV) infection or non alcoholic fatty liver disease (NAFLD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clara Balsano, MD

Role: STUDY_CHAIR

University of Roma La Sapienza

Locations

Departemnt of Internal Medicine, La Sapienza University

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Vincenzo Barnaba, MD

Role: CONTACT

vincenzo.barnaba@uniroma1.it

+39-064453994

Facility Contacts

Vincenzo Barnaba, MD

Role: primary

vincenzo.barnaba@uniroma1.it

+39-064453994

References

Maggio R, Viscomi C, Andreozzi P, D'Ettorre G, Viscogliosi G, Barbaro B, Gori M, Vullo V, Balsano C. Normocaloric low cholesterol diet modulates Th17/Treg balance in patients with chronic hepatitis C virus infection. PLoS One. 2014 Dec 22;9(12):e112346. doi: 10.1371/journal.pone.0112346. eCollection 2014.

Reference Type: DERIVED

PMID: 25532016 (View on PubMed)

Other Identifiers

717/12

Identifier Type: -

Identifier Source: org_study_id