About this trial
The project will establish a research cohort (called STELIR; STEatotisk Liver-risk In Rogaland) based on a biobank with an associated health register. The purpose is to collect, store and analyze biological material and clinical data from people at risk of steatotic liver disease (fatty liver disease). The research cohort will consist of individuals who agree to participate and will be followed over many years with planned examinations/tests at baseline, after 2 years, after 5 years and every 5 years thereafter. The STELIR cohort consists of individuals between 40 and 70 years of age who have one or more of the following risk factors: Obesity, type 2 diabetes or hazardous or harmful alcohol consumption.
The biological material and clinical data collected will be stored and used for research on liver-related disease risk, diagnostics and treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40 to 70 years at the time of inclusion
At least one of the following risk factors: Overweight or obesity, type 2 diabetes mellitus, risky or harmful alcohol consumption
Ability to provide written informed consent
Disqualifiers
Inability to give informed consent
Individuals outside the defined age range
Other conditions precluding participation based on investigator assessment
Trial population
The study population consists of adults recruited from the primary healthcare setting in Southern part of Rogaland County, Norway. Participants are identified through general practitioners and other primary care services and include community-dwelling individuals aged 40-70 years with metabolic and/or lifestyle-related risk factors for steatotic liver disease. All study visits and assessments are conducted at Stavanger University Hospital.
Trial design
Cohort
Prospective
Treatments tested in this trial
Routine study procedure
Other interventionRoutine study procedures include: Informed consent, medical history and clinical examination, structured questionnaires (lifestyle, alcohol use, metabolic risk factors), liver elastography, blood sample collection for clinical analyses and biobanking. Assessments are conducted at baseline, after 2 years, after 5 years, and subsequently every 5 years.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy of non-invasive diagnostic algorithms for identification of advanced liver fibrosis
Area under the receiver operating characteristic curve (AUROC) of non-invasive diagnostic algorithms (combinations of clinical variables, blood-based biomarkers, and liver elastography) for identification of advanced liver fibrosis in individuals at risk of steatotic liver disease.
Sponsors and contacts
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