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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)

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