The Role of Immune Semaphorins in NAFLD
Condition: Non-Alcoholic Fatty Liver Disease; Immune Response; Biomarkers; Liver Fibrosis; Non Alcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Study type: Observational

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

Detailed 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.
    

Intervention name(s): Evaluation of the degree of fibrosis and steatosis; Screening for the components of metabolic syndrome; Measurement of serum semaphorin concentrations; Identification of semaphorin gene polymorphisms
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): The degree of steatosis will be estimated using the controlled attenuation parameter (CAP), a method for grading steatosis by measuring the degree of ultrasound attenuation by hepatic fat using a process based on simultaneous transient elastography (TE) which measures the degree of fibrosis.; Anthropometric measures including body mass index (BMI), waist circumference (WC), waist hip ratio (WHR), and waist height ratio (WHtR) will be measured in all patients.
Results of the routine laboratory tests as part of the standard diagnostic procedure will be collected: bilirubin, AST, ALT, GGT, ALP, albumins, WBC, neutrophil-to-lymphocyte ratio, hemoglobin, platelet count, fasting glucose, triglycerides, cholesterol, HDL and LDL. Non-invasive scores of steatosis/fibrosis will be calculated (APRI, FIB4, NAFLD score). Patients will be screened for the components of metabolic syndrome.; Semaphorin concentration will be measured in patient sera by ELISA.; Semaphorin genes will be sequenced to identify semaphorin gene polymorphisms associated with NAFLD.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        120 patients diagnosed with NAFLD and 40 healthy controls will be included.