Chronic Liver Disease
Conditions
Keywords
non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, steatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, haemochromatosis, alfa-1-antitrypsin deficiency, chronic pancreatitis, chronic liver disease, inflammatory bowel disease, OMICS, Mass spectrometry
Brief summary
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.
Interventions
None listed
Sponsors
Hvidovre University Hospital
University of Copenhagen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients/healthy control participants (age 18 or above) who can give their informed consent * Suspected liver disease: * non-alcoholic steatohepatitis * alcoholic steatohepatitis * autoimmune hepatitis * primary biliary cholangitis * primary sclerosing cholangitis * inflammatory bowel disease * polycystic ovary syndrome * hereditary haemochromatosis * chronic pancreatitis * cystic fibrosis * alpha-1 antitrypsin deficiency
Exclusion criteria
Patients with: * malignant diseases * viral hepatitis * human immunodeficiency virus * contraindications to liver biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases. | 10 years | OMICS based analyses on plasma and liver tissue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To identify any metabolic disturbances within chronic liver diseases | Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min. | Collection of plasma during an oral glucose tolerance test measuring pancreatic and gut hormones |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fibrosis stage of the liver | 10 years | Non-invasive scoring systems (e.g. Fibroscan, Fib-4) |
Countries
Denmark
Contacts
Primary ContactAnne-Sofie H Jensen, MD
Backup ContactLise L Gluud, Professor
Outcome results
None listed