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| Name | Class |
|---|---|
| Croatian Science Foundation | OTHER_GOV |
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To goal is to identify semaphorins that are associated with NAFLD and to investigate their relationship with variable degrees of steatosis and fibrosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Non-alcoholic fatty liver disease | 120 patients diagnosed with NAFLD |
| |
| Controls | 40 healthy controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Staging of liver steatosis | The degree of steatosis will be estimated using the controlled attenuation parameter (CAP) in patients with NAFLD | 12 months |
| Staging of liver fibrosis | The stage of liver fibrosis will be assessed by transient elastography (TE) in patients with NAFLD |
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Inclusion Criteria:
Exclusion Criteria:
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120 patients diagnosed with NAFLD and 40 healthy controls will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Neven Papic, MD, PhD | University Hospital for Infectious Diseases Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital for Infectious Diseases Zagreb | Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36551769 | Result | 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. |
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|
| 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. |
|
| 12 months |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
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