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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03018990 |
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Date of registration:
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11/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial
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Scientific title:
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Date of first enrolment:
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November 9, 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03018990 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Aleksander Krag, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor, department of gastroenterology and hepatology, Odense University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liver Fibroses
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Alcohol-Induced Disorders
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Intervention(s)
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Other: Ethanol
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Primary Outcome(s)
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changes in concentrations of bacterial products in the liver vein
[Time Frame: Within 24 hours]
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Secondary Outcome(s)
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changes in concentrations of bacterial products in the peripheral vein system
[Time Frame: Within 24 hours]
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changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system
[Time Frame: Within 24 hours]
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changes in the gut microbiome
[Time Frame: Within 24 hours]
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changes in the liver metabolome, transcriptome and proteome
[Time Frame: Within 24 hours]
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Secondary ID(s)
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S-20160083
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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