Cognitive Function of Alcoholic Compensated Liver Cirrhosis

Alcoholic Liver Disease Clinical Trial

Official title:

Cognitive Function of Alcoholic Liver Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557774
• Other study ID #: COG
• Secondary ID: YR
• Status: Completed
• Start date: October 1, 2011
• Est. completion date: May 2020

Study information

• Verified date: September 2020
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2020
• Est. primary completion date: March 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Liver Cirrhosis
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

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, a-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

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital	Chuncheon	Gangwondo

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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), a-fetoprotein (AFP(ng/mL)), prothrombin time, blood glucose(mg/dL), triglycerides(mg/dL), and total cholesterol(mg/dL).	10 years
Primary	Cognitive function (Neuropsychological test)	Assessment to measure cognitive function using neuropsychological test	10 years
Primary	BMI	Compare the body mass index	10 years