Non-Alcoholic Fatty Liver DiseaseSepsisFATNCT04573543
The Role of Immune Semaphorins in NAFLD
An observational study of Non-Alcoholic Fatty Liver Disease and Immune Response, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
Trial summary
To goal is to identify semaphorins that are associated with NAFLD and to investigate their relationship with variable degrees of steatosis and fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Immune Response, Biomarkers
- What is being tested?
- Evaluation of the degree of fibrosis and steatosis, Screening for the components of metabolic syndrome and Measurement of serum semaphorin concentrations
- How many people
- 160 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 120 patients diagnosed with NAFLD and 40 healthy controls will be included.
Who may be able to join
- Patients diagnosed with NAFLD according to current guidelines (AASLD, EASL)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University Hospital for Infectious Diseases Zagreb
Zagreb, 10000
About this study
To goal is to identify semaphorins that are associated with NAFLD and to investigate their relationship with variable degrees of steatosis and fibrosis.
Read the 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
- Being tested
- Evaluation of the degree of fibrosis and steatosis, Screening for the components of metabolic syndrome, Measurement of serum semaphorin concentrations, Identification of semaphorin gene polymorphisms
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the degree of fibrosis and steatosisDiagnostic 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 syndromeDiagnostic 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 concentrationsDiagnostic test
Semaphorin concentration will be measured in patient sera by ELISA.
Identification of semaphorin gene polymorphismsDiagnostic test
Semaphorin genes will be sequenced to identify semaphorin gene polymorphisms associated with NAFLD.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Non-alcoholic fatty liver disease | 120 patients diagnosed with NAFLD Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of semaphorins in patients with NAFLD
Measurement of semaphorins concentration in serum of patients with NAFLD by enzyme-linked immunosorbent assay (ELISA)
Measured: 12 months
Identification of semaphorin gene polymorphism in patients with NAFLD
Sequencing of semaphorin genes in patients with NAFLD using Sanger sequencing
Measured: 12 months
Secondary outcomes (2)
Staging of liver steatosis
The degree of steatosis will be estimated using the controlled attenuation parameter (CAP) in patients with NAFLD
Measured: 12 months
Staging of liver fibrosis
The stage of liver fibrosis will be assessed by transient elastography (TE) in patients with NAFLD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital for Infectious Diseases, Croatia
- Sponsor type
- University, hospital or other
- Collaborators
- Croatian Science Foundation
- Responsible party
- Sponsor
- Investigators
- Neven Papic, MD, PhD, Principal investigator, University Hospital for Infectious Diseases Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573543
- Sponsor's protocol ID
- UHID-05
- Acronym
- SepsisFAT
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36551769
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Immune Semaphorins in NAFLD
- ClinicalTrials.gov ID
- NCT04573543
- Acronym / sponsor ID
- SepsisFAT / UHID-05
- Conditions
- Non-Alcoholic Fatty Liver Disease, Immune Response, Biomarkers, Liver Fibrosis, Non Alcoholic Steatohepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital for Infectious Diseases, CroatiaUniversity, hospital or other
- Collaborators
- Croatian Science Foundation
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Non-alcoholic fatty liver disease | – | 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 polymorphisms120 patients diagnosed with NAFLD |
| 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 polymorphisms40 healthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 120 patients diagnosed with NAFLD and 40 healthy controls will be included.
Key inclusion criteria (1 listed)
- Patients diagnosed with NAFLD according to current guidelines (AASLD, EASL)
Key exclusion criteria (8 listed)
- Immunosuppression
- Malignancies
- Autoimmune diseases
- Pregnancy
- HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the degree of fibrosis and steatosisThe 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 | Controls, Patients with Non-alcoholic fatty liver disease |
| Screening for the components of metabolic syndromeAnthropometric 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 | Controls, Patients with Non-alcoholic fatty liver disease |
| Measurement of serum semaphorin concentrationsSemaphorin concentration will be measured in patient sera by ELISA. | Diagnostic test | Controls, Patients with Non-alcoholic fatty liver disease |
| Identification of semaphorin gene polymorphismsSemaphorin genes will be sequenced to identify semaphorin gene polymorphisms associated with NAFLD. | Diagnostic test | Controls, Patients with Non-alcoholic fatty liver disease |
Primary outcome
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)
Identification of semaphorin gene polymorphism in patients with NAFLD
Time frame: 12 months
Sequencing of semaphorin genes in patients with NAFLD using Sanger sequencing
2 secondary outcomes
Staging of liver steatosis
Time frame: 12 months
Staging of liver fibrosis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Results publication: PubMed 36551769Samadan 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.
Related trials for Non-Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neven Papic, MD, PhD principal investigator
University Hospital for Infectious Diseases Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Immune Response, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of semaphorins in patients with NAFLD (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.