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临床试验/NCT04720560
NCT04720560招募中不适用

Role of Regulatory B Cells in the Pathogenesis of Metabolic Associated Fatty Liver Disease

Assiut University1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
174
试验地点
1
主要终点
Role of regulatory B cells in the pathogenesis of metabolic associated fatty liver disease

研究概览

简要总结

To evaluate the role of regulatory B cells in the pathogenesis of metabolic associated fatty liver disease patients.

详细描述

The prevalence of non-alcoholic fatty liver disease (NAFLD) increases rapidly in recent decades. NAFLD has become a major public health problem in the whole world, and it is considered as the main cause for the chronic liver diseases (Feng, 2020).

Eslam et al. (2020) recently published an international expert consensus statement about a new definition of metabolic dysfunction-associated fatty liver disease (MAFLD) to replace non-alcoholic fatty liver disease (NAFLD).

The new nomenclature of MAFLD is based on the presence of steatosis in >5% of hepatocytes and the absence of excessive alcohol consumption or other causes of chronic liver disease, diagnosis of MAFLD could be established on the presence of hepatic steatosis in combination with one of the following three criteria: overweight/obesity; presence of type 2 diabetes mellitus; or evidence of metabolic dysregulation (Eslam et al. (2020).

Metabolic dysregulation is defined as having at least 2 of the following metabolic risk abnormalities: high waist circumference, high blood pressure, high cholesterol, pre-diabetes, insulin resistance, and high plasma C-reactive protein levels (Eslam et al. (2020).

New diagnostic criteria for MAFLD were proposed, in which hepatic steatosis (HS) detected either by imaging techniques, blood biomarkers/scores or by liver histology (Bedogni et al., 2006; Wong et al., 2019).

研究设计

研究类型
Observational
观察模型
Case Only
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

  • All patients aged >18 years old and was diagnosed as fatty liver based on clinical examination, laboratory investigations and imaging techniques.

排除标准

  • 1-Patients aged ≤18 years old. 2-Pregnancy. 3-Presence of malignancy. 4-Type I DM. 5-Fatty liver patients on treatment by statin derivatives or other medications. 6- Fatty liver patients undergone bariatric surgeries.

结局指标

主要结局

Role of regulatory B cells in the pathogenesis of metabolic associated fatty liver disease

时间窗: baseline

To evaluate the role of regulatory B cells in the pathogenesis of metabolic associated fatty liver disease patients.

次要结局

未报告次要终点

研究者

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

Amira Mohammed Abdel Mowgod

Doctor

Assiut University

研究点 (1)

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