Risk Factors for Advanced Fibrosis Among FLD Patients

Diabetes Mellitus, Type 2 Clinical Trial

— FLD_FU_HUS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05971082
• Other study ID #: FLD_FU_HUS
• Status: Enrolling by invitation
• Start date: August 24, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Liver Cirrhosis
• NAFLD

Intervention

Other:
• Follow-up
Follow-up study of progression/remission of liver disease

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Pfizer

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of liver disease	Proportion of participants who have developed liver fibrosis or steatosis since the index date (in 2010-2018)	5-15 years
Primary	remission of fatty liver disease	Proportion of participants with remission of fatty liver (= no detectable liver fat) since the index date (in 2010-2018)	5-15 years