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

Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Liver Disease

• Study Type: Observational
• Enrollment (Anticipated): 335

Contacts and Locations

• Study Contact: Name: Anne-Sofie H Jensen, MD; Phone Number: +4538621966; Email: anne-sofie.houlberg.jensen@regionh.dk
• Study Contact Backup: Name: Lise L Gluud, Professor; Phone Number: +4538621964; Email: lise.lotte.gluud.01@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Hvidovre University Hospital
    • Contact: Anne-Sofie H Jensen, MD; Phone Number: +4538621966; Email: anne-sofie.houlberg.jensen@regionh.dk
    • Contact: Lise L Gluud, Professor; Phone Number: +4538621964; Email: lise.lotte.gluud.01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.	OMICS based analyses on plasma and liver tissue	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify any metabolic disturbances within chronic liver diseases	Collection of plasma during an oral glucose tolerance test measuring pancreatic and gut hormones	Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibrosis stage of the liver	Non-invasive scoring systems (e.g. Fibroscan, Fib-4)	10 years

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Hvidovre University Hospital
• Investigators: Principal Investigator: Lise L Gluud, Professor, Hvidovre University Hospital; Principal Investigator: Nicolai J Wewer Albrechtsen, MD, PhD, NNF Center for Protein Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2020
• Primary Completion (ANTICIPATED): August 1, 2036
• Study Completion (ANTICIPATED): August 1, 2036

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (ACTUAL): April 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: non-alcoholic fatty liver disease; non-alcoholic steatohepatitis; steatosis; inflammatory bowel disease; chronic pancreatitis; Mass spectrometry; chronic liver disease; primary biliary cholangitis; primary sclerosing cholangitis; autoimmune hepatitis; haemochromatosis; alfa-1-antitrypsin deficiency; OMICS
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: FALL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No