Cognitive Function of Alcoholic Compensated Liver Cirrhosis

Sponsor
Chuncheon Sacred Heart Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04557774
Collaborator
(none)
110
1
103
1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive function test

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
110 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cognitive Function of Alcoholic Liver Disease Patients
Actual Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Liver cirrhosis group

All included patients were asymptomatic at the baseline with no evidence of neurological impairment. Patients with a history of moderate alcohol drinking plus hepatitis B/C virus infection, medication for sedation, MELD (Model for End-stage Liver Disease) score of more than 20, OHE, seizure, head trauma, stroke, dementia, Parkinson's disease, or any kind of focal neurologic deficits were excluded. Any patients who were suspected of alcohol induced direct neurologic damages such as Wernicke's encephalopathy, alcohol induced spinal cord disease, or alcohol induced peripheral nerve disease were excluded. After evaluating the data including the laboratory findings, image findings, endoscopic findings, and medical records of all these patients, as well as liver biopsy findings for some patients, we sub-classified these 88 patients into two groups: alcoholic LC and viral LC. Finally, 80 patients (viral: 37; alcohol: 43) with compensated LC were prospectively considered in this study.

Other: Cognitive function test
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
  • Outcome Measures

    Primary Outcome Measures

    1. Liver function [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) [10 years]

      Assessment to measure cognitive function using neuropsychological test

    3. BMI [10 years]

      Compare the body mass index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital Chuncheon Gangwondo Korea, Republic of 200-704

    Sponsors and Collaborators

    • Chuncheon Sacred Heart Hospital

    Investigators

    • Principal Investigator: Ki Tae Suk, Hallym University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ki Tae Suk, Proffesor, Chuncheon Sacred Heart Hospital
    ClinicalTrials.gov Identifier:
    NCT04557774
    Other Study ID Numbers:
    • COG
    • YR
    First Posted:
    Sep 22, 2020
    Last Update Posted:
    Sep 22, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ki Tae Suk, Proffesor, Chuncheon Sacred Heart Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2020