About this trial
Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult patients/healthy control participants (age 18 or above) who can give their informed consent
non-alcoholic steatohepatitis
alcoholic steatohepatitis
autoimmune hepatitis
Disqualifiers
malignant diseases
viral hepatitis
human immunodeficiency virus
contraindications to liver biopsy
Trial population
Potentially eligible patients will be identified and recruited among those referred with suspected liver disease at the outpatient clinic at the Gastro Unit, Copenhagen University Hospital Hvidovre, Denmark. Healthy control participants will be recruited through advertisements at forsoegsperson.dk and posters. Posters will be mounted in neutral places at Copenhagen University Hospital Hvidovre and at neutral places at the Panum Institute. Copenhagen University Hospital Hvidovre is a large regional hospital with more than 3500 employees and the Panum Institute is a large building complex in Copenhagen, Denmark that houses the Faculty of Health and Medical Sciences.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.
OMICS based analyses on plasma and liver tissue
Secondary outcomes
To identify any metabolic disturbances within chronic liver diseases
Collection of plasma during an oral glucose tolerance test measuring pancreatic and gut hormones
Other outcomes
Fibrosis stage of the liver
Non-invasive scoring systems (e.g. Fibroscan, Fib-4)
Sponsors and contacts
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University of Copenhagen
Lead sponsor
Hvidovre University Hospital
Collaborator