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Risk Factors for Advanced Fibrosis Among FLD Patients

Risk Factors for Advanced Fibrosis Among Fatty Liver Disease Patients Identified Through Pharese-screening of Miaging Reports

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05971082
Acronym
FLD_FU_HUS
Enrollment
1000
Registered
2023-08-02
Start date
2023-08-24
Completion date
2025-12-31
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Liver Cirrhosis, NAFLD

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.

Interventions

OTHERFollow-up

Follow-up study of progression/remission of liver disease

Sponsors

Pfizer
CollaboratorINDUSTRY
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression of liver disease5-15 yearsProportion of participants who have developed liver fibrosis or steatosis since the index date (in 2010-2018)
remission of fatty liver disease5-15 yearsProportion of participants with remission of fatty liver (= no detectable liver fat) since the index date (in 2010-2018)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026