Screening for NAFLD in Flanders

• Sponsor: Hasselt University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04647409
• Collaborator: (none)
• Enrollment: 10,000
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 50.2
• Patients Per Site Per Month: 199.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Other: screening	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Screening for Non-Alcoholic Fatty Liver Disease (NAFLD) in a General Practitioner Population, in Flanders, Belgium.
• Actual Study Start Date: Oct 26, 2020
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. CLDQ-NAFLD [baseline]

   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

2. 36-Item Short Form Survey (SF-36) [baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hasselt University	Hasselt		Belgium	3500

Sponsors and Collaborators

• Hasselt University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geert Robaeys, Principal Investigator, Hasselt University
• ClinicalTrials.gov Identifier: NCT04647409
• Other Study ID Numbers: SCREEFLAN-01
• First Posted: Nov 30, 2020
• Last Update Posted: Apr 8, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Apr 8, 2022