An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Copenhagen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.

OMICS based analyses on plasma and liver tissue

Time frame
10 years

Secondary outcomes

1

To identify any metabolic disturbances within chronic liver diseases

Collection of plasma during an oral glucose tolerance test measuring pancreatic and gut hormones

Time frame
Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min.

Other outcomes

1

Fibrosis stage of the liver

Non-invasive scoring systems (e.g. Fibroscan, Fib-4)

Time frame
10 years

Sponsors and contacts

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University of Copenhagen

Lead sponsor

Hvidovre University Hospital

Collaborator