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

Non-Alcoholic Fatty Liver Disease Clinical Trial

— NAFLD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06097039
• Other study ID #: Diagnosis of the NAFLD
• Status: Enrolling by invitation
• Start date: August 1, 2023
• Est. completion date: January 20, 2024

Study information

• Verified date: October 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

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.
• 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).

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig	Sharkia

Sponsors (3)

Lead Sponsor	Collaborator
Zagazig University	Benha University, Suez University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Friedman SL, Neuschwander-Tetri BA, Rinella M, Sanyal AJ. Mechanisms of NAFLD development and therapeutic strategies. Nat Med. 2018 Jul;24(7):908-922. doi: 10.1038/s41591-018-0104-9. Epub 2018 Jul 2. — View Citation

Sasso M, Tengher-Barna I, Ziol M, Miette V, Fournier C, Sandrin L, Poupon R, Cardoso AC, Marcellin P, Douvin C, de Ledinghen V, Trinchet JC, Beaugrand M. Novel controlled attenuation parameter for noninvasive assessment of steatosis using Fibroscan((R)): — View Citation

Schwimmer JB, Middleton MS, Behling C, Newton KP, Awai HI, Paiz MN, Lam J, Hooker JC, Hamilton G, Fontanesi J, Sirlin CB. Magnetic resonance imaging and liver histology as biomarkers of hepatic steatosis in children with nonalcoholic fatty liver disease. — View Citation

WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004 Jan 10;363(9403):157-63. doi: 10.1016/S0140-6736(03)15268-3. Erratum In: Lancet. 2004 Mar 13;363(9412):902 — View Citation

Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess fetuin-A serum concentration	Serum fetuin-A serum concentrations of fetuin-A was measured by using a human fetuin-A sandwich enzyme-linked immunosorbent assay (ELISA) kit.	30 minutes.
Primary	To measure liver stiffness and fibrosis degree	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%.	30 minutes
Primary	Number of participants with fetuin-A serum concentration and liver stiffness degree using FibroScan	Number of participants with fetuin-A serum concentration and liver stiffness degree using FibroScan	30 minutes