NCT06445335

Brief Summary

To determine the prevalence of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Mar 2019Nov 2026

Study Start

First participant enrolled

March 1, 2019

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

7.7 years

First QC Date

May 21, 2024

Last Update Submit

November 24, 2025

Conditions

NAFLDT2DType 2 DiabetesFatty Liver, Nonalcoholic

Outcome Measures

Primary Outcomes (1)

  • Prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus (T2DM) patients

    To determine the prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus (T2DM) patients followed at the department of Endocrinology in Ziekenhuis Oost-Limburg (ZOL), Genk, Belgium by means of FibroScan measurements.

    Baseline

Study Arms (1)

FibroScan

OTHER
Diagnostic Test: FibroScan

Interventions

FibroScanDIAGNOSTIC_TEST

Performance of a FibroScan measurement.

FibroScan

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years of age
  • Having type 2 diabetes mellitus (T2DM)
  • Written informed consent obtained

You may not qualify if:

  • Excessive alcohol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mathieu Struyve, MD

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

June 6, 2024

Study Start

March 1, 2019

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations

BE(1)