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NCT Number: NCT06097039

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

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

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. To assess fetuin-A serum concentration

    Time frame: 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.

  2. To measure liver stiffness and fibrosis degree

    Time frame: 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%.

  3. Number of participants with fetuin-A serum concentration and liver stiffness degree using FibroScan

    Time frame: 30 minutes

    Number of participants with fetuin-A serum concentration and liver stiffness degree using FibroScan

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Collaborators

  • Benha University
  • Suez University

Registry information

Official study title

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

Acronym: NAFLD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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