NAFLDPAD1ZOLNCT06445361
Prevalence of NAFLD in T1DM Patients
A study testing FibroScan in people with NAFLD and Type 1 Diabetes, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
To determine the prevalence of NAFLD in T1DM patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD, Type 1 Diabetes, Fatty Liver, Nonalcoholic
- What is being tested?
- FibroScan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2023to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1DM
- ≥ 18 years of age
- Written informed consent obtained
Who cannot join
- Excessive alcohol use
- Exclusion of other causes of liver disease and secondary causes of liver steatosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Leen Heyens, MsC, 089 21 20 55 ext. +32, NAFLDstudie@zol.be
About this study
Official title: The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 1 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium
To determine the prevalence of NAFLD in T1DM patients.
- Conditions
- NAFLD, Type 1 Diabetes, Fatty Liver, Nonalcoholic
- Being tested
- FibroScan
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScanDiagnostic test
Performance of a FibroScan measurement to determine steatosis and fibrosis.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Other | FibroScan measurement Receives: Diagnostic Test: FibroScan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jul 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445361
- Sponsor's protocol ID
- Z-2022007
- Acronym
- PAD1ZOL
- Status last verified
- Jul 2025
- First submitted
- 28 Feb 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 1 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium
- ClinicalTrials.gov ID
- NCT06445361
- Acronym / sponsor ID
- PAD1ZOL / Z-2022007
- Conditions
- NAFLD, Type 1 Diabetes, Fatty Liver, Nonalcoholic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the prevalence of NAFLD in T1DM patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | Other | Diagnostic Test: FibroScanFibroScan measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- T1DM
- ≥ 18 years of age
- Written informed consent obtained
Key exclusion criteria (2 listed)
- Excessive alcohol use
- Exclusion of other causes of liver disease and secondary causes of liver steatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroScanPerformance of a FibroScan measurement to determine steatosis and fibrosis. | Diagnostic test | Study cohort |
Primary outcome
Prevalence of NAFLD in T1DM
Time frame: During the intervention
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.
Prevalence of fibrosis in T1DM
Time frame: During the intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibroScan in people with NAFLD and Type 1 Diabetes, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leen Heyens, MsC (089 21 20 55 ext. +32, nafldstudie@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of NAFLD in T1DM (time frame: During the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.