An observational study in Alcoholic Liver Disease, sponsored by Chuncheon Sacred Heart Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 22 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-22.
Sponsored by Chuncheon Sacred Heart Hospital · Observational
Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis
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.
2,081 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.
This study's enrollment of 110 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Chuncheon Sacred Heart Hospital is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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
Also known as: Laboratory, imaging, neuropsychological tests
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).
Time frame: 10 years
Cognitive function (Neuropsychological test)
Assessment to measure cognitive function using neuropsychological test
Time frame: 10 years
BMI
Compare the body mass index
Time frame: 10 years
Plan to share: No
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Chuncheon Sacred Heart Hospital