Skip to main content
OpenTrials
Completed

NCT Number: NCT04573543

The Role of Immune Semaphorins in NAFLD

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Biomarkers Digestive System Diseases Fatty Liver Fibrosis Immune Response Liver Cirrhosis Liver Diseases Liver Fibrosis Non Alcoholic Steatohepatitis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital for Infectious Diseases Zagreb

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of the degree of fibrosis and steatosis

Diagnostic Test

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.

Screening for the components of metabolic syndrome

Diagnostic Test

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.

Measurement of serum semaphorin concentrations

Diagnostic Test

Semaphorin concentration will be measured in patient sera by ELISA.

Identification of semaphorin gene polymorphisms

Diagnostic Test

Semaphorin genes will be sequenced to identify semaphorin gene polymorphisms associated with NAFLD.

Primary outcomes

  1. Detection of semaphorins in patients with NAFLD

    Time frame: 12 months

    Measurement of semaphorins concentration in serum of patients with NAFLD by enzyme-linked immunosorbent assay (ELISA)

  2. Identification of semaphorin gene polymorphism in patients with NAFLD

    Time frame: 12 months

    Sequencing of semaphorin genes in patients with NAFLD using Sanger sequencing

Secondary outcomes

  1. Staging of liver steatosis

    Time frame: 12 months

    The degree of steatosis will be estimated using the controlled attenuation parameter (CAP) in patients with NAFLD

  2. Staging of liver fibrosis

    Time frame: 12 months

    The stage of liver fibrosis will be assessed by transient elastography (TE) in patients with NAFLD

Sponsors and collaborators

Lead sponsor

University Hospital for Infectious Diseases, Croatia

Other

Collaborators

  • Croatian Science Foundation

Registry information

Acronym: SepsisFAT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 5, 2020
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.