Alcoholic Liver DiseaseNCT04557774
Cognitive Function of Alcoholic Compensated Liver Cirrhosis
An observational study of Alcoholic Liver Disease, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis Read more about this study
- Who is it for?
- Ages 22 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Liver Disease
- What is being tested?
- Cognitive function test
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2011to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All of them are agree to provide it to investigation.
Who may be able to join
- Those who agreed to participate in this study and signed a written consent
- Those who have no evidence of neurological impairment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwondo, 200-704
About this study
Official title: Cognitive Function of Alcoholic Liver Disease Patients
Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis
Read the 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.
- Conditions
- Alcoholic Liver Disease
- Being tested
- Cognitive function test
- Keywords
- Hepatic encephalopathy, Liver cirrhosis, Cognition, Alcohol, BMI
- Medical subject headings
- Liver Diseases, Alcoholic, Hepatic Encephalopathy, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive function testOther
Also called Laboratory, imaging, neuropsychological tests
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cognitive function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 years
Cognitive function (Neuropsychological test)
Assessment to measure cognitive function using neuropsychological test
Measured: 10 years
BMI
Compare the body mass index
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Oct 2011
- Primary completion1 Mar 2013
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Tae Suk, Chuncheon Sacred Heart Hospital
- Investigators
- Ki Tae Suk, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557774
- Sponsor's protocol ID
- COG
- Other IDs
- YR
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function of Alcoholic Liver Disease Patients
- ClinicalTrials.gov ID
- NCT04557774
- Acronym / sponsor ID
- COG
- Conditions
- Alcoholic Liver Disease
- Keywords
- Hepatic encephalopathy, Liver cirrhosis, Cognition, Alcohol, BMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 1 Mar 2013 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Differences in cognitive function between patients with viral and alcoholic compensated liver cirrhosis
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver cirrhosis group | – | Other: Cognitive function testAll 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. |
Who may qualify
- Ages
- 22 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All of them are agree to provide it to investigation.
Key inclusion criteria (2 listed)
- Those who agreed to participate in this study and signed a written consent
- Those who have no evidence of neurological impairment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive function testAlso: Laboratory, imaging, neuropsychological testsLaboratory 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 | Liver cirrhosis group |
Primary outcome
Liver function
Time frame: 10 years
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).
Cognitive function (Neuropsychological test)
Time frame: 10 years
Assessment to measure cognitive function using neuropsychological test
BMI
Time frame: 10 years
Compare the body mass index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Tae Suk principal investigator
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Liver Disease, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver function (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.