---
title: Alpha-Glutathione-S-Transferase (AlphaGST) and MARINA Index in Metabolic-Dysfunction-Associated-Steatotic-Liver-Disease (MASLD)
nct_id: NCT05804955
overall_status: COMPLETED
sponsor: University of Campania Luigi Vanvitelli
study_type: OBSERVATIONAL
primary_condition: Fatty Liver
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05804955.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05804955"
ct_last_update_post_date: 2024-05-16
last_seen_at: "2026-05-12T06:45:08.013Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Alpha-Glutathione-S-Transferase (AlphaGST) and MARINA Index in Metabolic-Dysfunction-Associated-Steatotic-Liver-Disease (MASLD)

**Official Title:** Alpha-Glutathione-S-Transferase (AlphaGST) and the MARINA Index as a Novel Predictive Biomarker and Composite Tool for Disease Impairment in the MASLD Context

**NCT ID:** [NCT05804955](https://clinicaltrials.gov/study/NCT05804955)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 260
- **Lead Sponsor:** University of Campania Luigi Vanvitelli
- **Conditions:** Fatty Liver
- **Start Date:** 2017-01-02
- **Completion Date:** 2022-07-01
- **CT.gov Last Update:** 2024-05-16

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

```
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
```

## Arms

- **Training Cohort** — 200 MASLD patients
- **Validation Cohort** — 60 MASLD patients

## Primary Outcomes

- **Alpha-Glutathione-S-Transferase (alpha GST) prediction of advanced fibrosis** _(time frame: 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** _(time frame: 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 Outcomes

- **MARINA index in the prediction of acute cardiovascular events** _(time frame: five years)_

## Locations (1)

- University of Campania Luigi Vanvitelli, Naples, Italy

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of campania luigi vanvitelli|naples||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05804955.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05804955*  
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