Risk Factors for Advanced Fibrosis Among FLD Patients

NCT05971082 | Unknown

• 1 other identifier: FLD_FU_HUS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; Liver Cirrhosis; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Progression of liver disease

  Proportion of participants who have developed liver fibrosis or steatosis since the index date (in 2010-2018)

  5-15 years

• 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

Study Arms (1)

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

Interventions

Follow-up OTHER

Follow-up study of progression/remission of liver disease

Recall study

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Pfizer: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples, blood DNA and RNA

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tiinamaija Tuomi, MD, PhD

  Chief Physician

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: August 2, 2023
• Study Start: August 24, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)