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临床试验/NCT05357352
NCT05357352已完成不适用

Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis

Methodist Health System1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2019年5月24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
263
试验地点
1
主要终点
NAS score lover

研究概览

简要总结

Few studies have evaluated an extensive list of possible risk factors for NAFLD for their association with presence and severity of histologic features. We wish to conduct a retrospective study on these possible factors (including demographics, comorbid diseases, and medications) for their association, if any, with severity of histopathologic findings. This study hypothesize that certain risk factors, specifically those contributing to or consisting of metabolic syndrome, will have higher NASH Fibrosis stages.

详细描述

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in Western countries, and is projected to become one of the foremost indications for liver transplantation (2). Both NAFLD and its most severe histopathologic subtype, non-alcoholic steatohepatitis (NASH) can progress to cirrhosis and its complications including hepatic malignancy, and are thus an important target for study. It is well-known that several risk factors are associated with the development of NAFLD, including obesity, type 2 diabetes mellitus, and metabolic syndrome (1), however their association with the presence and severity of histologic features of NAFLD/NASH has not been extensively examined. This study can help determine prognostic indicators for NALFD/NASH which can be useful in its prevention and treatment.

This is a retrospective chart review and de-identified data analysis. Data will be extracted from the patient database from the Methodist Liver Institute from April 2013 - June 2020. Patients with confirmed NAFLD/NASH via liver biopsy will be selected and NAFLD Activity Score and Fibrosis stage will be assessed. Data will then be collected on demographics, comorbid diseases, and medications from EPIC EMR system used by Methodist Health System.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Patients identified to have biopsy-proven NASH within April 2013 - June 2020
  • Minimum age 18, no upper limit of age
  • Patients with complete records

排除标准

  • Age <18 years
  • Incomplete records
  • Diseases other than NASH

结局指标

主要结局

NAS score lover

时间窗: April 2013 - June 2020

Severity of Nonalcoholic fatty liver disease and fibrosis staging. The NAS is a measure of grade and is the sum of numerical scores applied to steatosis (0-3), hepatocellular ballooning (0-2), and lobular inflammation (0-3). Accordingly, the NAS ranges from 0 to 8 (see Table 12.3). The NAS is one of the few grading systems for NAFLD that has been externally validated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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