Fatty Liver
Conditions
Keywords
Metabolic dysfunction Associated Steatotic Liver Disease, liver fibrosis, liver cirrhosis, non-invasive biomarkers, cardiovascular risk
Brief summary
AlphaGST represents a liver enzyme whose serologic levels progressively increase in alcoholic and viral chronic hepatitis according to the worsening of liver fibrosis. However, its diagnostic and prognostic usefulness in Metabolic-dysfunction-Associated-Steatotic-Liver-Disease has never been explored. The investigators aimed to assess the alphaGST levels in Metabolic-dysfunction-Associated-Steatotic-Liver-Disease patients affected by different stages of liver fibrosis, and, by using a new-designed Metabolic Abnormalities Related to lipids- Insulin resistance-AlphaGST levels (MARINA) index, to evaluate its role as a novel non-invasive tool in the disease staging stratification, identification of the advanced fibrosis and prediction of 5-years acute cardiovascular events occurrence. The investigators enrolled 30 ehalthy controls and 200 metabolic dysfunction-associated steatotic liver disease patients (Training cohort) (TrC). As a validation cohort (VlC), between January 2018 and May 2019, 60 MASLD patients were consecutively enrolled (Validation Cohort - VlC) All Metabolic-dysfunction-Associated- Steatotic-Liver-Disease patients received an ultrasound-guided percutaneous liver biopsy for the disease staging. Liver stiffness measurement, NAFLD fibrosis score, Fibrosis-4, and body mass index-aspartate aminotransferase/Platelet Ratio-Diabetes scores as well as the MARINA index were determined. Naïve-acute cardiovascular events patients were subsequently followed up over 5 years to record acute cardiovascular events occurrence.
Interventions
None listed
Sponsors
University of Campania Luigi Vanvitelli
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
* age between 18 and 80 years * MASLD diagnosis
Exclusion criteria
* presence of chronic inflammatory diseases * acute or chronic kidney diseases * rheumatoid arthritis, systemic lupus erythematosus, or other major systemic inflammatory diseases or tumors * ongoing infections * alcohol or drug abuse history * other etiologies of chronic liver damage * previous hepatocellular carcinoma diagnosis * use of hepatoprotective drugs * decompensated liver cirrhosis (Child-Pugh B and Child-Pugh C) at the moment of the enrollment or in the previous 12 months * psychological/psychiatric problems that could have invalidated the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alpha-Glutathione-S-Transferase (alpha GST) prediction of advanced fibrosis | baseline | The diagnostic accuracy of the alpha-Glutathione-S-Transferase (alphaGST) blood levels (pg/ml) in the prediction of hepatic histological-proved advanced fibrosis |
| MARINA Index prediction of advanced fibrosis | baseline | The diagnostic accuracy of the MARINA index in the prediction of hepatic histological-proved advanced fibrosis. The MARINA index was calculated by combining the following variables: HLD \> 43.5 mg/dl (no: 1 point; yes: 2 points); HbA1c \> 5.5% (no: 1 point; yes: 2 points); AlphaGST \> 3917 pg/ml (no: 2 point; yes: 4 point). MARINA index total scores ranged from 3 to 8 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MARINA index in the prediction of acute cardiovascular events | five years | The accuracy of the MARINA index in the prediction of Acute Cardiovascular Events 5 years occurrence. The MARINA index was calculated by combining the following variables: HLD \> 43.5 mg/dl (no: 1 point; yes: 2 points); HbA1c \> 5.5% (no: 1 point; yes: 2 points); AlphaGST \> 3917 pg/ml (no: 2 point; yes: 4 point). MARINA index total scores ranged from 3 to 8 points. |
Countries
Italy
Outcome results
None listed