An observational study in Non-Alcoholic Fatty Liver Disease, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Zagazig University · Observational
The work investigate the role of fetuin-A in the diagnosis and assessment of the severity of non-alcoholic fatty liver disease (NAFLD).
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).
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 100 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
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patients who were admitted to the university hospitals with inclusion criteria
Exclusion Criteria:
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):
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):
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.
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).
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.
Time frame: 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%.
Time frame: 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
Time frame: 30 minutes
Plan to share: No — to keep participant privacy
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Zagazig University