Cognitive Function of Alcoholic Compensated Liver Cirrhosis

Cognitive Function of Alcoholic Liver Disease Patients

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

Study Overview

• Status: Completed
• Conditions: Alcoholic Liver Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwondo
    • Chuncheon, Gangwondo, Korea, Republic of, 200-704
      • Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All of them are agree to provide it to investigation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver function	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).	10 years
Cognitive function (Neuropsychological test)	Assessment to measure cognitive function using neuropsychological test	10 years
BMI	Compare the body mass index	10 years

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Investigators: Principal Investigator: Ki Tae Suk, Hallym University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2011
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (ACTUAL): September 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cognition; Alcohol; BMI; Liver cirrhosis; Hepatic encephalopathy
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Fibrosis; Alcohol-Induced Disorders; Liver Diseases; Liver Cirrhosis; Liver Diseases, Alcoholic
• Other Study ID Numbers: COG; YR (OTHER: Hallym university)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No