跳至主要内容
临床试验/NCT05804955
NCT05804955已完成不适用

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

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2017年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
1
主要终点
Alpha-Glutathione-S-Transferase (alpha GST) prediction of advanced fibrosis

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 80 years
  • MASLD diagnosis

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

次要结局

  • MARINA index in the prediction of acute cardiovascular events(five years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Federico

Professor

University of Campania "Luigi Vanvitelli"

研究点 (1)

Loading locations...

相似试验

Alpha-Glutathione-S-Transferase (AlphaGST) and... | 临床试验