Clinical trial NCT04573543: The Role of Immune Semaphorins in NAFLD
Official title: The Role of Immune Semaphorins in NAFLD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease
Immune Response
Biomarkers
Liver Fibrosis
Non Alcoholic Steatohepatitis
Lead sponsor: University Hospital for Infectious Diseases, Croatia
Sponsor class: OTHER
Collaborators: name: Croatian Science Foundation
First posted: 2020-10-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of semaphorins in patients with NAFLD
timeFrame: 12 months
measure: Identification of semaphorin gene polymorphism in patients with NAFLD
timeFrame: 12 months
Secondary outcomes:
measure: Staging of liver steatosis
timeFrame: 12 months
measure: Staging of liver fibrosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital for Infectious Diseases Zagreb
Study officials:
affiliation: University Hospital for Infectious Diseases Zagreb
name: Neven Papic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samadan L, Papic N, Mijic M, Knezevic Stromar I, Gasparov S, Vince A. Do Semaphorins Play a Role in Development of Fibrosis in Patients with Nonalcoholic Fatty Liver Disease? Biomedicines. 2022 Nov 23;10(12):3014. doi: 10.3390/biomedicines10123014.