Back to resultsAlcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial
Primary Purpose
Liver Fibroses, Alcohol-Induced Disorders
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ethanol
Sponsored by
About this trial
This is an interventional basic science trial for Liver Fibroses
Eligibility Criteria
Inclusion Criteria:
- Alcoholic liver fibrosis, non-alcoholic steatohepatitis or liver-healthy individuals
And all of following:
- Bodymass > 50 kg
- Able to be fasting and abstinent on the day of intervention
- international ratio <1.5 and platelets >100 x 10^9, 7 days before the intervention day
- Informed consent
Exclusion Criteria:
- Antibiotics during the last 4 weeks
- Total alcohol abstinence
- Desire of total alcohol abstinence
- Other causes of liver disease suspected (viral, autoimmune, haemochromatosis, Wilsons diseases, alfa 1 antitrypsin deficiency or drug induced)
- Cirrhosis
- Insulin dependent diabetes mellitus
- Incapable to follow the protocol instructions
- Pregnancy
- Primary or secondary liver cancer
- Severe comorbidity
- Allergic to the contrast media iohexol
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Alcoholic liver fibrosis
Non-alcoholic steatohepatitis
Healthy control
Arm Description
Outcomes
Primary Outcome Measures
changes in concentrations of bacterial products in the liver vein
Secondary Outcome Measures
changes in concentrations of bacterial products in the peripheral vein system
changes in the gut microbiome
changes in the liver metabolome, transcriptome and proteome
changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system
Full Information
NCT ID
NCT03018990
First Posted
January 11, 2017
Last Updated
March 6, 2020
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03018990
Brief Title
Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
November 12, 2018 (Actual)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effects of acute alcohol challenge on the gut and liver axis.
Detailed Description
To study the role of acute alcohol challenge on the intestine permeability and inflow of bacterial products to the liver in participants with alcoholic liver disease, non-alcoholic steatohepatitis and healthy controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibroses, Alcohol-Induced Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alcoholic liver fibrosis
Arm Type
Active Comparator
Arm Title
Non-alcoholic steatohepatitis
Arm Type
Active Comparator
Arm Title
Healthy control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Ethanol
Intervention Description
1 milliliter per kilogram body weight adjusted for elevated body mass index
Primary Outcome Measure Information:
Title
changes in concentrations of bacterial products in the liver vein
Time Frame
Within 24 hours
Secondary Outcome Measure Information:
Title
changes in concentrations of bacterial products in the peripheral vein system
Time Frame
Within 24 hours
Title
changes in the gut microbiome
Time Frame
Within 24 hours
Title
changes in the liver metabolome, transcriptome and proteome
Time Frame
Within 24 hours
Title
changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system
Time Frame
Within 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Alcoholic liver fibrosis, non-alcoholic steatohepatitis or liver-healthy individuals
And all of following:
Bodymass > 50 kg
Able to be fasting and abstinent on the day of intervention
international ratio <1.5 and platelets >100 x 10^9, 7 days before the intervention day
Informed consent
Exclusion Criteria:
Antibiotics during the last 4 weeks
Total alcohol abstinence
Desire of total alcohol abstinence
Other causes of liver disease suspected (viral, autoimmune, haemochromatosis, Wilsons diseases, alfa 1 antitrypsin deficiency or drug induced)
Cirrhosis
Insulin dependent diabetes mellitus
Incapable to follow the protocol instructions
Pregnancy
Primary or secondary liver cancer
Severe comorbidity
Allergic to the contrast media iohexol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksander Krag, MD, PhD
Organizational Affiliation
Professor, department of gastroenterology and hepatology, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
34401690
Citation
Israelsen M, Kim M, Suvitaival T, Madsen BS, Hansen CD, Torp N, Trost K, Thiele M, Hansen T, Legido-Quigley C, Krag A; MicrobLiver Consortium. Comprehensive lipidomics reveals phenotypic differences in hepatic lipid turnover in ALD and NAFLD during alcohol intoxication. JHEP Rep. 2021 Jun 29;3(5):100325. doi: 10.1016/j.jhepr.2021.100325. eCollection 2021 Oct.
Results Reference
derived
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Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial
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