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

Recruiting

• Conditions: Chronic Liver Disease

• Registration Number: NCT05335603
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-24
• Status Verified: 2022-04
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Last Update Submitted: 2022-04-12
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19
• Primary Completion: 2036-08
• Study Completion: 2036-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 335

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.	10 years	OMICS based analyses on plasma and liver tissue

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark