Skip to main content
OpenTrials
Completed

NCT Number: NCT04557774

Cognitive Function of Alcoholic Compensated Liver Cirrhosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcoholic Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Chemically-Induced Disorders Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Diseases, Alcoholic Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

22 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwondo, 200-704, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Cognitive function test

Other

Laboratory and imaging test

  • Biochemical serum test: total bilirubin, alanine aminotransferase (ALT), haptoglobin, aspartate aminotransferase (AST), gamma glutamyltranspeptidase (GGT), alkaline phosphatase (ALP), albumin, blood urea nitrogen, creatinine, α-fetoprotein (AFP), prothrombin time, blood glucose, triglycerides, and total cholesterol.
  • Baseline evaluations: family and alcohol history, X-ray, electrocardiography, blood tests for electrolyte, liver function, and viral markers

Neuropsychological test

-Attention, Language, Visuospatial, Memory, Frontal/executive

Other names: Laboratory, imaging, neuropsychological tests

Primary outcomes

  1. Liver function

    Time frame: 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).

  2. Cognitive function (Neuropsychological test)

    Time frame: 10 years

    Assessment to measure cognitive function using neuropsychological test

  3. BMI

    Time frame: 10 years

    Compare the body mass index

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Official study title

Cognitive Function of Alcoholic Liver Disease Patients

Important dates

Study start
2011
Primary completion
2013
Study completion
2020
First posted
Sep 22, 2020
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.