Study Results
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Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2020-09-01
2022-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with Non-alcoholic fatty liver disease
120 patients diagnosed with NAFLD
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.
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.
Measurement of serum semaphorin concentrations
Semaphorin concentration will be measured in patient sera by ELISA.
Identification of semaphorin gene polymorphisms
Semaphorin genes will be sequenced to identify semaphorin gene polymorphisms associated with NAFLD.
Controls
40 healthy controls
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.
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.
Measurement of serum semaphorin concentrations
Semaphorin concentration will be measured in patient sera by ELISA.
Identification of semaphorin gene polymorphisms
Semaphorin genes will be sequenced to identify semaphorin gene polymorphisms associated with NAFLD.
Interventions
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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.
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.
Measurement of serum semaphorin concentrations
Semaphorin concentration will be measured in patient sera by ELISA.
Identification of semaphorin gene polymorphisms
Semaphorin genes will be sequenced to identify semaphorin gene polymorphisms associated with NAFLD.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Croatian Science Foundation
OTHER_GOV
University Hospital for Infectious Diseases, Croatia
OTHER
Responsible Party
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Principal Investigators
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Neven Papic, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital for Infectious Diseases Zagreb
Locations
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University Hospital for Infectious Diseases Zagreb
Zagreb, , Croatia
Countries
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References
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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.
Other Identifiers
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UHID-05
Identifier Type: -
Identifier Source: org_study_id
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