Screening for NAFLD in Flanders

Screening for Non-Alcoholic Fatty Liver Disease (NAFLD) in a General Practitioner Population, in Flanders, Belgium.

In the Belgian adult population more than half, and numbers are still increasing, of the population is overweight or obese. These people are at risk to develop NAFLD. However, we lack epidemiological data in Belgium. Therefore, it is important to do epidemiological studies to investigate NAFLD prevalence and disease severity based on a non-invasive approach and evaluate how patients are to be referred.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: screening

• Study Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geert Robaeys, prof. dr.; Phone Number: +32 89 32 65 05; Email: geert.robaeys@zol.be
• Study Contact Backup: Name: Leen Heyens, drs.; Phone Number: +32 89 21 20 55; Email: leen.heyens@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Recruiting
    • Hasselt University
    • Contact: Leen Heyens, drs.; Phone Number: +32 89 21 20 55; Email: leen.heyens@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years or older,
• able to understand Dutch,
• able to understand the informed consent

Exclusion Criteria:

• secondary causes of steatosis
• excessive alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: participants	Other: screening; The determination of the prevalence of NAFLD in a general population in Flanders, Belgium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLDQ-NAFLD	The determination of the prevalence of NAFLD in a general population in Flanders, Belgium by using A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis	baseline
36-Item Short Form Survey (SF-36)	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.	baseline

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Study Chair: Leen Heyens, drs., Hasselt University; Principal Investigator: Geert Robaeys, prof. dr., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: SCREEFLAN-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No