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

NCT06097039 | Completed

• 1 other identifier: Diagnosis of the NAFLD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

fetuin-A; fibroscan; NAFLD

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• 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

Study Arms (2)

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

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):

Interventions

abdominal U/S DEVICE

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.

Healthy subjects group; NAFLD subjects group

Fibroscan with Controlled Attenuated Parameter (CAP scan): DEVICE

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; NAFLD subjects group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who were admitted to the university hospitals with inclusion criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead
• Suez University: collaborator
• Benha University: collaborator

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

Location

Related Publications (6)

• 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.

  PMID: 29967350 BACKGROUND

• 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.

  PMID: 26707365 BACKGROUND

• 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.

  PMID: 14726171 RESULT

• 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)): validation in chronic hepatitis C. J Viral Hepat. 2012 Apr;19(4):244-53. doi: 10.1111/j.1365-2893.2011.01534.x. Epub 2011 Oct 13.

  PMID: 22404722 RESULT

• 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. Hepatology. 2015 Jun;61(6):1887-95. doi: 10.1002/hep.27666. Epub 2015 Feb 5.

  PMID: 25529941 RESULT

• Elhoseeny MM, Abdulaziz BA, Mohamed MA, Elsharaby RM, Rashad GM, Othman AAA. Fetuin-A: a relevant novel serum biomarker for non-invasive diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD): a retrospective case-control study. BMC Gastroenterol. 2024 Jul 18;24(1):226. doi: 10.1186/s12876-024-03310-y.

  PMID: 39026172 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Amira A Othman, PhD

  Lecturer of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 24 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 24, 2023
• Study Start: January 1, 2023
• Primary Completion: January 20, 2024
• Study Completion: February 20, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)