NAFLD: Fetuin-A, a Promising Serum Biomarker for Diagnosis of Non-Alcoholic Fatty Liver Disease

Sponsor

Zagazig University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06097039

Collaborator

Suez University (Other), Benha University (Other)

100

Enrollment

Location

5.7

Anticipated Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The work investigate the role of fetuin-A in the diagnosis and assessment of the severity of non-alcoholic fatty liver disease (NAFLD).

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Device: abdominal U/S Device: Fibroscan with Controlled Attenuated Parameter (CAP scan):

Detailed Description

The prevalence of nonalcoholic fatty liver disease (NAFLD), which has recently become one of the most prevalent chronic liver illnesses, is about 25% worldwide. NAFLD is a progressive liver disease that can cause fibrosis and ultimately cirrhosis, in contrast to simple hepatic steatosis, which is considered to be a benign condition. The sole way to diagnose NAFLD and stage liver fibrosis has historically been a liver biopsy. There are a number of issues with this method, though. A liver biopsy is a painful and invasive diagnostic procedure that carries a risk of consequences.

Fetuin-A, also called the 2-Heremans-Schmid glycoprotein, belongs to the fetuin group of serum-binding proteins and is largely produced by hepatocytes. It is a phosphorylated glycoprotein. Fetuin-A can cause insulin resistance in the target organs, including the liver and skeletal muscle, as it is an endogenous tyrosine kinase inhibitor. A strong correlation between the level of circulating fetuin-A and the onset and progression of NAFLD has been described by accumulating lines of evidence, but the findings have been contradictory.

The investigators want to find out how fetuin-A affects the diagnosis and evaluation of the severity of non-alcoholic fatty liver disease (NAFLD) and to reveal the relationship between fetuin-A and the NAFLD fibrosis score (NFS).

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Fetuin-A, a Promising Serum Biomarker for Diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD)

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jan 20, 2024

Anticipated Study Completion Date :

Jan 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
NAFLD subjects group The group including 50 cases with NAFLD, the diagnosis was based on abdominal U/S and Fibroscan with CAP with or without elevated liver enzymes	Device: abdominal U/S A convex transducer with a frequency range of 2-5 MHz was used for ultrasound. Based on a visual study of the intensity of the echogenicity and under the assumption that the gain setting is optimal, various (0-3) degrees of steatosis have been proposed. Grade I occurs when the echogenicity is simply increased; grade II occurs when the echogenic liver obscures the echogenic walls of the portal vein branches; and grade III occurs when the echogenic liver obscures the diaphragmatic contour. Device: Fibroscan with Controlled Attenuated Parameter (CAP scan): Using FibroScan502 (Echosens, Paris, France), liver stiffness measurement (LSM) and CAP were acquired. Before the treatment, all subjects will be instructed to fast for at least 8 hours. The median of 10 measurements served as the LSM score, which was only deemed credible if at least 10 successful acquisitions were made and the IQR-to-median ratio of the 10 acquisitions was below 30%. If 10 successful acquisitions are made, CAP measures were deemed trustworthy and taken into account in the final analysis. CAP graded the degree of hepatic steatosis using the M probe in accordance with standard cut-off values (S1=222-232; S2= 233-289; and S3 290 dB/m).
Healthy subjects group The group including 50 healthy subjects as a control group with normal liver in transabdominal ultrasonography and normal liver enzymes	Device: abdominal U/S A convex transducer with a frequency range of 2-5 MHz was used for ultrasound. Based on a visual study of the intensity of the echogenicity and under the assumption that the gain setting is optimal, various (0-3) degrees of steatosis have been proposed. Grade I occurs when the echogenicity is simply increased; grade II occurs when the echogenic liver obscures the echogenic walls of the portal vein branches; and grade III occurs when the echogenic liver obscures the diaphragmatic contour. Device: Fibroscan with Controlled Attenuated Parameter (CAP scan): Using FibroScan502 (Echosens, Paris, France), liver stiffness measurement (LSM) and CAP were acquired. Before the treatment, all subjects will be instructed to fast for at least 8 hours. The median of 10 measurements served as the LSM score, which was only deemed credible if at least 10 successful acquisitions were made and the IQR-to-median ratio of the 10 acquisitions was below 30%. If 10 successful acquisitions are made, CAP measures were deemed trustworthy and taken into account in the final analysis. CAP graded the degree of hepatic steatosis using the M probe in accordance with standard cut-off values (S1=222-232; S2= 233-289; and S3 290 dB/m).

Arm

Intervention/Treatment

NAFLD subjects group

The group including 50 cases with NAFLD, the diagnosis was based on abdominal U/S and Fibroscan with CAP with or without elevated liver enzymes

Device: abdominal U/S

A convex transducer with a frequency range of 2-5 MHz was used for ultrasound. Based on a visual study of the intensity of the echogenicity and under the assumption that the gain setting is optimal, various (0-3) degrees of steatosis have been proposed. Grade I occurs when the echogenicity is simply increased; grade II occurs when the echogenic liver obscures the echogenic walls of the portal vein branches; and grade III occurs when the echogenic liver obscures the diaphragmatic contour.

Device: Fibroscan with Controlled Attenuated Parameter (CAP scan):

Using FibroScan502 (Echosens, Paris, France), liver stiffness measurement (LSM) and CAP were acquired. Before the treatment, all subjects will be instructed to fast for at least 8 hours. The median of 10 measurements served as the LSM score, which was only deemed credible if at least 10 successful acquisitions were made and the IQR-to-median ratio of the 10 acquisitions was below 30%. If 10 successful acquisitions are made, CAP measures were deemed trustworthy and taken into account in the final analysis. CAP graded the degree of hepatic steatosis using the M probe in accordance with standard cut-off values (S1=222-232; S2= 233-289; and S3 290 dB/m).

Healthy subjects group

The group including 50 healthy subjects as a control group with normal liver in transabdominal ultrasonography and normal liver enzymes

Device: abdominal U/S

Device: Fibroscan with Controlled Attenuated Parameter (CAP scan):

Outcome Measures

Primary Outcome Measures

To assess fetuin-A serum concentration [30 minutes.]
Serum fetuin-A serum concentrations of fetuin-A was measured by using a human fetuin-A sandwich enzyme-linked immunosorbent assay (ELISA) kit.
To measure liver stiffness and fibrosis degree [30 minutes]
liver stiffness measurement (LSM) and fibrosis degreewere obtained using FibroScan502 (Echosens, Paris, France). The LSM score was represented by the median of 10 measurements and was considered reliable only if at least 10 successful acquisitions were obtained and the IQR-to-median ratio of the 10 acquisitions was ≤30%.
Number of participants with fetuin-A serum concentration and liver stiffness degree using FibroScan [30 minutes]
Number of participants with fetuin-A serum concentration and liver stiffness degree using FibroScan

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients who were admitted to the university hospitals with inclusion criteria

Exclusion Criteria:

Patients who are younger than 18 years old,
Patients with a history of high alcohol consumption (more than 40 g/day for men and 20 g/day for women) over the previous five years,
Patients who have concurrent hepatitis B and hepatitis C viral infections
Patients with hepatobiliary malignancy, Wilson's disease, alpha-one antitrypsin deficiency, and autoimmune hepatitis,
Pregnant women
Patients who take steatogenic pharmaceuticals including amiodarone, valproic acid, antiretrovirals, methotrexate, and tetracyclines, or NAFLD treatments like vitamin E, metformin, and thiazolidinediones