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RecruitingNCT06445361PAD1ZOLUpdated Jul 28, 2025

Prevalence of NAFLD in T1DM Patients

An interventional study of FibroScan in NAFLD, Type 1 Diabetes and Fatty Liver, Nonalcoholic, sponsored by Ziekenhuis Oost-Limburg. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by Ziekenhuis Oost-Limburg · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Jul 2023, registered Feb 2024).
  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To determine the prevalence of NAFLD in T1DM patients.

02

Conditions studied

  • NAFLD
  • Type 1 Diabetes
  • Fatty Liver, Nonalcoholic
03

In context

Non-alcoholic Fatty Liver Disease

1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 138 is above the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Ziekenhuis Oost-Limburg is the lead sponsor of 66 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • T1DM
  • ≥ 18 years of age
  • Written informed consent obtained

Exclusion criteria

Exclusion Criteria:

  • Excessive alcohol use
  • Exclusion of other causes of liver disease and secondary causes of liver steatosis
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
138 participants (estimated)

Study arms

  • Other
    Study cohort

    FibroScan measurement

    Diagnostic Test: FibroScan

Interventions

  • Diagnostic testFibroScan

    Performance of a FibroScan measurement to determine steatosis and fibrosis.

06

What researchers measure

Primary outcomes

  1. Prevalence of NAFLD in T1DM

    To determine the prevalence of steatosis in a cohort of T1DM patients followed at the Departments of Endocrinology in ZOL by means of the FibroScan® device with controlled attenuation parameter (CAP) measurements.

    Time frame: During the intervention

  2. Prevalence of fibrosis in T1DM

    To determine the prevalence of fibrosis in a cohort of T1DM patients followed at the Departments of Endocrinology in ZOL by means of the FibroScan® device with vibration controlled attenuation parameter (VCTE) measurements.

    Time frame: During the intervention

07

Study locations

1 of 1 sites recruiting
  • Ziekenhuis Oost-Limburg
    Genk, Limburg 3600, Belgium
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — During the study period IPD will not be made available for other researchers. When the study is completed and results are reported, IPD can be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06445361
Lead sponsor
Ziekenhuis Oost-Limburg
Responsible party
Sponsor
First posted
Jun 6, 2024
Start date
Jul 1, 2023
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Jul 28, 2025

Study contacts

Leen Heyens, MsC
Contact
nafldstudie@zol.be
089 21 20 55 ext. +32

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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