Back to resultsScreening for NAFLD in Flanders
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
screening
Sponsored by
About this trial
This is an interventional screening trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
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
Sites / Locations
- Hasselt UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
participants
Arm Description
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04647409
Brief Title
Screening for NAFLD in Flanders
Official Title
Screening for Non-Alcoholic Fatty Liver Disease (NAFLD) in a General Practitioner Population, in Flanders, Belgium.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
participants
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
screening
Intervention Description
The determination of the prevalence of NAFLD in a general population in Flanders, Belgium
Primary Outcome Measure Information:
Title
CLDQ-NAFLD
Description
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
Time Frame
baseline
Title
36-Item Short Form Survey (SF-36)
Description
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.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geert Robaeys, prof. dr.
Phone
+32 89 32 65 05
Email
geert.robaeys@zol.be
First Name & Middle Initial & Last Name or Official Title & Degree
Leen Heyens, drs.
Phone
+32 89 21 20 55
Email
leen.heyens@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leen Heyens, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leen Heyens, drs.
Phone
+32 89 21 20 55
Email
leen.heyens@uhasselt.be
12. IPD Sharing Statement
Learn more about this trial
Screening for NAFLD in Flanders
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