Alpha-Glutathione-S-Transferase (AlphaGST) and MARINA Index in Metabolic-Dysfunction-Associated-Steatotic-Liver-Disease (MASLD)

University of Campania Luigi Vanvitelli260 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

260

Conditions

Fatty Liver

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Alpha-Glutathione-S-Transferase (alpha GST) prediction of advanced fibrosis

The diagnostic accuracy of the alpha-Glutathione-S-Transferase (alphaGST) blood levels (pg/ml) in the prediction of hepatic histological-proved advanced fibrosis

Time frame: baseline

MARINA Index prediction of advanced fibrosis

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.

Time frame: baseline

Secondary Outcomes

MARINA index in the prediction of acute cardiovascular events

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.

Time frame: five years