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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04557774
Other study ID # COG
Secondary ID YR
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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