Economic Burden of NAFLD

November 24, 2025 updated by: Geert Robaeys, Hasselt University

The Economic Burden of Non-Alcoholic Fatty Liver Disease Patients in Flanders, Belgium

To determine the economic burden of NAFLD (Non-Alcoholic-Fatty-Liver Disease) patients in Belgium, Flanders by means of a bottom-up approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Hasselt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • having NAFLD as was diagnosed by FibroScan®,
  • 18 years or older
  • BMI ≥ 25 kg/m²

Exclusion Criteria:

  • unable to give informed consent
  • >70 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAFLD patients
Non-Alcoholic Fatty Liver Disease patients
Other: Determination of the economic burden NAFLD patients
Determination of the economic burden NAFLD patients (Healthcare costs, patient costs, burden of disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iMTA MCQ
Time Frame: baseline
Healthcare cost measured with the iMTA MCQ (Institute for Medical Technology Assessment Medical Consumption Questionnaire). The volumes of used healthcare costs were multiplied with the unit costs of these corresponding services.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iMTA MCQ
Time Frame: Baseline
Patient cost measured with the iMTA MCQ (Institute for Medical Technology Assessment Medical Consumption Questionnaire). The volumes of used healthcare costs were multiplied with the unit costs of these corresponding services.
Baseline
EuroQol-5D-5L
Time Frame: baseline
: Health related quality of life questionnaire EuroQol-5D-5L is used. Five levels are score in 5 dimensions. It is scaled from 0 to 100%. A higher score indicates a higher quality of life.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EB-NAFLD-DGP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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