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

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Fatty Liver

Study type: Observational

Funder types: Other

Identifiers

NCT05804955

530/2016

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

260 participants in 2 patient groups

Training Cohort

Description:

200 MASLD patients

Validation Cohort

Description:

60 MASLD patients