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The Role of Immune Semaphorins in NAFLD (SepsisFAT)

U

University Hospital for Infectious Diseases, Croatia

Status

Completed

Conditions

Immune Response
Non Alcoholic Steatohepatitis
Biomarkers
Liver Fibrosis
Non-Alcoholic Fatty Liver Disease

Treatments

Diagnostic Test: Measurement of serum semaphorin concentrations
Diagnostic Test: Screening for the components of metabolic syndrome
Diagnostic Test: Identification of semaphorin gene polymorphisms
Diagnostic Test: Evaluation of the degree of fibrosis and steatosis

Study type

Observational

Funder types

Other

Identifiers

NCT04573543
UHID-05

Details and patient eligibility

About

To goal is to identify semaphorins that are associated with NAFLD and to investigate their relationship with variable degrees of steatosis and fibrosis.

Full description

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease associated with systemic changes in immune response. Semaphorins were recently recognized as one of the key regulators of immune responses; while some suppress immune cells activation, proliferation, and production of inflammatory cytokines, others stimulate immune responses. We have previously shown that semaphorins are associated with pathogenesis of viral hepatitis and progression of fibrosis. However, their role in NAFLD is unknown. The hypothesis of this project is that semaphorins are regulators of inflammation in patients with NAFLD. This study is designed as a prospective, non-interventional study. The main aims are: (1) to analyze serum concentration of semaphorins in patients with NAFLD; (2) to analyze tissue expression of semaphorins in patients with NAFLD; (3) to analyze semaphorin gene polymorphisms associated with NAFLD. Semaphorins could be a novel diagnostic and prognostic biomarker as well as targets for immune modulation.

Enrollment

160 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients diagnosed with NAFLD according to current guidelines (AASLD, EASL)

Exclusion criteria

  • Immunosuppression
  • Malignancies
  • Autoimmune diseases
  • Pregnancy
  • HIV
  • Chronic viral hepatitis
  • Presence of other chronic liver disease (hemochromatosis, Wilson's disease, toxic hepatitis, deficiency of alpha-1-antitrypsin, liver autoimmune disease)
  • Consumption of alcohol > 20 g/day

Trial design

160 participants in 2 patient groups

Patients with Non-alcoholic fatty liver disease
Description:
120 patients diagnosed with NAFLD
Treatment:
Diagnostic Test: Evaluation of the degree of fibrosis and steatosis
Diagnostic Test: Measurement of serum semaphorin concentrations
Diagnostic Test: Screening for the components of metabolic syndrome
Diagnostic Test: Identification of semaphorin gene polymorphisms
Controls
Description:
40 healthy controls
Treatment:
Diagnostic Test: Evaluation of the degree of fibrosis and steatosis
Diagnostic Test: Measurement of serum semaphorin concentrations
Diagnostic Test: Screening for the components of metabolic syndrome
Diagnostic Test: Identification of semaphorin gene polymorphisms

Trial contacts and locations

1

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Central trial contact

Branimir Gjurasin, MD

Data sourced from clinicaltrials.gov

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