NCT04573543

The Role of Immune Semaphorins in NAFLD

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: University Hospital for Infectious Diseases, Croatia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Evaluation of the degree of fibrosis and steatosis	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.
DIAGNOSTIC_TEST	Screening for the components of metabolic syndrome	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.
DIAGNOSTIC_TEST	Measurement of serum semaphorin concentrations	Semaphorin concentration will be measured in patient sera by ELISA.
DIAGNOSTIC_TEST	Identification of semaphorin gene polymorphisms	Semaphorin genes will be sequenced to identify semaphorin gene polymorphisms associated with NAFLD.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-09-01
• Completion: 2022-03-01
• First posted: 2020-10-05
• Last updated: 2023-08-30

Locations

1 site across 1 country: Croatia