FLD_FU_HUS: Risk Factors for Advanced Fibrosis Among FLD Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Recall study Recruited individuals aged 20-60 at index imaging date invited for follow-up with liver elastography and fat prosentage measurement |
Other: Follow-up
Follow-up study of progression/remission of liver disease
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Outcome Measures
Primary Outcome Measures
- Progression of liver disease [5-15 years]
Proportion of participants who have developed liver fibrosis or steatosis since the index date (in 2010-2018)
- remission of fatty liver disease [5-15 years]
Proportion of participants with remission of fatty liver (= no detectable liver fat) since the index date (in 2010-2018)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Liver imaging results in the Helsinki University Hospital datalake 2010-2018 and a finding of fatty liver disease (without liver cirrhosis)
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Age 20-60 years at the time of the index imaging (2010-2018)
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Helsinki University Central Hospital
- Pfizer
Investigators
- Study Director: Tiinamaija Tuomi, MD, PhD, Chief Physician
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FLD_FU_HUS