NCT06445361

Brief Summary

To determine the prevalence of NAFLD in T1DM patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress95%
Jul 2023Jul 2026

Study Start

First participant enrolled

July 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

February 28, 2024

Last Update Submit

July 22, 2025

Conditions

NAFLDType 1 DiabetesFatty Liver, Nonalcoholic

Outcome Measures

Primary Outcomes (2)

  • 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.

    During the intervention

  • 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.

    During the intervention

Study Arms (1)

Study cohort

OTHER

FibroScan measurement

Diagnostic Test: FibroScan

Interventions

FibroScanDIAGNOSTIC_TEST

Performance of a FibroScan measurement to determine steatosis and fibrosis.

Study cohort

Eligibility Criteria

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

You may qualify if:

  • T1DM
  • ≥ 18 years of age
  • 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

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Leen Heyens, MsC

CONTACT

089 21 20 55nafldstudie@zol.be

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

February 28, 2024

First Posted

June 6, 2024

Study Start

July 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

BE(1)