Clinical trial NCT05971082: Risk Factors for Advanced Fibrosis Among FLD Patients
Official title: Risk Factors for Advanced Fibrosis Among Fatty Liver Disease Patients Identified Through Pharese-screening of Miaging Reports
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: NAFLD
Liver Cirrhosis
Diabetes Mellitus, Type 2
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2023-08-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will invite a random sample of 1000-1500 individuals with FLD (aged 20-60 years at the time of the previous imaging) to a follow-up study. See eligibility criteria for details.

Brief summary: The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.

To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. Within the data lake of Helsinki University Hospital, they identified a large number of individuals with or without FLD. The investigators will now randomly invite 1000-1500 individuals with FLD to a follow-up study including investigation of metabolism and progression of liver disease (elastography, blood tests) as well as gathering life-style information. Register data on previous diagnoses and medication will be used to evaluate cardiovascular disease.

Detailed description: The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.

To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. This allows them to study also individuals who have had abdominal imaging for any reason (usually not for suspected liver disease). Within the data lake of Helsinki University Hospital, the investigators identified 61,271 individuals with FLD and 155,521 without. The investigators have obtained national register data on their diagnosed diseases and medication.

The investigators will now invite a random sample of 1000-1500 individuals with FLD (aged 20-60 years at the time of the previous imaging) to a follow-up study. Progression of liver disease will be studied by elastography, measurement of fat content and a blood sample for fibrosis markes (ELF score). The participants' metabolism will be evaluated with several laboraroty tests and an i.v. glucagon tolerance test and amino acid response. Questionnaires will be used to obtain life-style information.

Eligibility criteria: Inclusion Criteria:

* Liver imaging results in the Helsinki University Hospital datalake 2010-2018 and a finding of fatty liver disease (without liver cirrhosis)
* Age 25-70 years(20-60 yrs at the time of the index imaging (2010-2018)
* Biobank consent with the Helsinki Biobank to be contacted for possible studies

Exclusion Criteria:

Liver cirrhosis at index imaging date; pregnancy; active treatment for cancer

Primary outcomes:
measure: Progression of liver disease
timeFrame: 5-15 years
measure: remission of fatty liver disease
timeFrame: 5-15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Chief Physician
name: Tiinamaija Tuomi, MD, PhD
role: STUDY_DIRECTOR
References: