The Role of Immune Semaphorins in NAFLD

NCT04573543 | Completed

• 1 other identifier: UHID-05
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Detection of semaphorins in patients with NAFLD

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

  12 months

• Identification of semaphorin gene polymorphism in patients with NAFLD

  Sequencing of semaphorin genes in patients with NAFLD using Sanger sequencing

  12 months

Secondary Outcomes (2)

• Staging of liver steatosis

  12 months

• Staging of liver fibrosis

  12 months

Study Arms (2)

Patients with Non-alcoholic fatty liver disease

120 patients diagnosed with NAFLD

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

Controls

40 healthy controls

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

Interventions

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.

Controls; Patients with Non-alcoholic fatty liver disease

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.

Controls; Patients with Non-alcoholic fatty liver disease

Measurement of serum semaphorin concentrations DIAGNOSTIC_TEST

Semaphorin concentration will be measured in patient sera by ELISA.

Controls; Patients with Non-alcoholic fatty liver disease

Identification of semaphorin gene polymorphisms DIAGNOSTIC_TEST

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

Controls; Patients with Non-alcoholic fatty liver disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

120 patients diagnosed with NAFLD and 40 healthy controls will be included.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital for Infectious Diseases, Croatia: lead
• Croatian Science Foundation: collaborator

Study Sites (1)

University Hospital for Infectious Diseases Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (1)

• 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.

  PMID: 36551769 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Neven Papic, MD, PhD

  University Hospital for Infectious Diseases Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 5, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: August 30, 2023

Record last verified: 2020-09

Locations

CR (1)