Cognitive Function of Alcoholic Compensated Liver Cirrhosis

NCT04557774 | Completed DMC

• 2 other identifiers: COGYR
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcoholic Liver Disease

Keywords

Hepatic encephalopathy; Liver cirrhosis; Cognition; Alcohol; BMI

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Cognitive function test OTHER

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 cirrhosis group

Eligibility Criteria

• Age: 22 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All of them are agree to provide it to investigation.

You may qualify if:

• Those who agreed to participate in this study and signed a written consent
• Those who have no evidence of neurological impairment

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwondo, 200-704, South Korea

Location

MeSH Terms

Conditions

Liver Diseases, Alcoholic; Hepatic Encephalopathy; Liver Cirrhosis

Interventions

Neuropsychological Tests; Laboratories; X-Rays

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Ki Tae Suk

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 22, 2020
• Study Start: October 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)