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临床试验/NCT04557774
NCT04557774已完成不适用

Cognitive Function of Alcoholic Liver Disease Patients

Chuncheon Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2011年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
BMI

研究概览

简要总结

Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis

详细描述

Hepatic encephalopathy (HE) is one of the important complications of liver cirrhosis (LC). HE exhibits alterations in cognitive, psychomotor-intellectual, emotional, behavioral, or fine-motor functions. Approximately 22-74 % of patients with non-fulminant HE have MHE with a frequency proportional to the patient age and the severity of the liver disease. Patients with MHE exhibit disability in most functional behaviors such as social connection, alertness, emotional behavior, sleep, work, and leisure.

Alcohol consumption itself has a toxic effect on the brain. It has been documented that there is a neuronal loss in the cerebral cortex, hypothalamus, hippocampus, septal region, and cerebellum of an alcoholic brain.

The major causes of LC are hepatitis B/C viral infection and chronic alcohol consumption. The most widely accepted theory of HE pathogenesis is that toxic substances derived from the gut affect cerebral function after liver dysfunction or portosystemic shunting. This proposed pathogenetic mechanism could apply to viral compensated LC. However, it is difficult to explain the development of MHE in patients with alcoholic LC in this manner.

Therefore, patients with alcoholic LC may have different cognitive dysfunction as compared to patients with viral LC.

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
22 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those who agreed to participate in this study and signed a written consent
  • Those who have no evidence of neurological impairment

排除标准

  • Those who have decompensated liver cirrhosis
  • Those who have a high MELD score (≥20)
  • Those who have OHE during admission
  • Those who have parients' refusal

结局指标

主要结局

BMI

时间窗: 10 years

Compare the body mass index

Liver function

时间窗: 10 years

Compare the liver enzyme level Serum biochemical parameters included total bilirubin(mg/dL), alanine aminotransferase(ALT(IU/L)), haptoglobin(mg/dL), aspartate aminotransferase (AST (IU/L)), gamma glutamyltranspeptidase (GGT(IU/L)), alkaline phosphatase (ALP(IU/L)), albumin(g/dL), blood urea nitrogen(mg/dL), creatinine(mg/dL), α-fetoprotein (AFP(ng/mL)), prothrombin time, blood glucose(mg/dL), triglycerides(mg/dL), and total cholesterol(mg/dL).

Cognitive function (Neuropsychological test)

时间窗: 10 years

Assessment to measure cognitive function using neuropsychological test

次要结局

未报告次要终点

研究者

发起方
Chuncheon Sacred Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ki Tae Suk

Proffesor

Chuncheon Sacred Heart Hospital

研究点 (1)

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