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

NCT05335603 | Recruiting

• 1 other identifier: FALL
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease

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

Outcome Measures

Primary Outcomes (1)

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

  OMICS based analyses on plasma and liver tissue

  10 years

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• Fibrosis stage of the liver

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with:
• malignant diseases
• viral hepatitis
• human immunodeficiency virus
• contraindications to liver biopsy

Sponsors & Collaborators

• University of Copenhagen: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

RECRUITING

Related Publications (1)

• Jensen AH, Ytting H, Nielsen AB, Werge MP, Rashu EB, Hetland LE, Thing M, Nabilou P, Burisch J, Junker AE, Hobolth L, Mortensen C, Tofteng F, Bendtsen F, Moller S, Vyberg M, Serizawa RR, Winther-Sorensen M, Kellemann JS, Gluud LL, Wewer Albrechtsen NJ. Diagnostics of Autoimmune Hepatitis Enabled by Non-Invasive Clinical Proteomics. Aliment Pharmacol Ther. 2025 Nov;62(9):901-919. doi: 10.1111/apt.70273. Epub 2025 Jul 17.

  PMID: 40671462 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Liver tissue, plasma, serum, whole blood.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Hepatitis, Autoimmune; Liver Cirrhosis, Biliary; Cholangitis, Sclerosing; Hemochromatosis; Pancreatitis, Chronic; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Hepatitis; Autoimmune Diseases; Immune System Diseases; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cholangitis; Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Overload; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pancreatitis; Pancreatic Diseases; Chronic Disease; Disease Attributes; Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases

Study Officials

• Lise L Gluud, Professor

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Nicolai J Wewer Albrechtsen, MD, PhD

  NNF Center for Protein Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sofie H Jensen, MD

CONTACT

+4538621966; anne-sofie.houlberg.jensen@regionh.dk

Lise L Gluud, Professor

CONTACT

+4538621964; lise.lotte.gluud.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: August 24, 2020
• Primary Completion (Estimated): August 1, 2036
• Study Completion (Estimated): August 1, 2036
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

DK (1)