NCT05035043

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

3.2 years

First QC Date

August 30, 2021

Last Update Submit

November 24, 2025

Conditions

Non-Alcoholic Fatty Liver DiseaseNAFLD

Outcome Measures

Primary Outcomes (1)

  • iMTA MCQ

    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 Outcomes (2)

  • iMTA MCQ

    Baseline

  • EuroQol-5D-5L

    baseline

Study Arms (1)

NAFLD patients

EXPERIMENTAL

Non-Alcoholic Fatty Liver Disease patients

Other: Determination of the economic burden NAFLD patients

Interventions

Determination of the economic burden NAFLD patientsOTHER

Determination of the economic burden NAFLD patients (Healthcare costs, patient costs, burden of disease

NAFLD patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unable to give informed consent
  • \>70 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Geert Robaeys, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Leen Heyens

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 5, 2021

Study Start

March 1, 2021

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations

BE(1)