NAFLD (Nonalcoholic Fatty Liver Disease)P-CORIGANCT07146815
PolyCystic Ovary Syndrome as Suggested Risk Group for Non-Alcoholic Fatty Liver Disease
A study testing FibroScan and MRI PDFF in people with NAFLD (Nonalcoholic Fatty Liver Disease) and Polycystic Ovarian Syndrome (PCOS), run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
To study the prevalence, non-invasive diagnostics and evolution of non-alcoholic-fatty-liver-disease (NAFLD) in patients with polycystic ovary syndrome (PCOS) Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- NAFLD (Nonalcoholic Fatty Liver Disease), Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- FibroScan and MRI PDFF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Nov 2022to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (i.e. older than 18 years of age)
- The diagnosis of PCOS based on expert opinion (i.e. according to Rotterdam criteria)
- Able to understand patients information concerning this study
- Able to give written informed consent
Who cannot join
- Excessive alcohol use: ≥ 2u (20g)/day for females
- Secondary causes of liver steatosis
- Other causes of endocrinological disease
- Diseases that might mimic PCOS
Trial locations and contacts
1 site in 1 country.
About this study
To study the prevalence, non-invasive diagnostics and evolution of non-alcoholic-fatty-liver-disease (NAFLD) in patients with polycystic ovary syndrome (PCOS)
- Being tested
- FibroScan, MRI PDFF
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Polycystic Ovary Syndrome
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 the prevalence of liver steatosis.
MRI PDFFDiagnostic test
Performance of an MRI-PDFF to determine amount of liver steatosis.
| Study group | Role | What they receive |
|---|---|---|
| PCOS group | Other | Screening of women with PCOS Receives: Diagnostic Test: FibroScan; Diagnostic Test: MRI PDFF |
| Control group | Other | Screening of women without PCOS Receives: Diagnostic Test: FibroScan; Diagnostic Test: MRI PDFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NAFLD
To study the prevalence of NAFLD in a population diagnosed with PCOS measured with Controlled Attenuation Parameter (CAP)
Measured: Baseline and at follow-up 1 year later.
Prevalence of NAFLD in PCOS
To measure the prevalence of NAFLD in women with PCOS using the MRI-PDFF technique.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start29 Nov 2022
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD (Nonalcoholic Fatty Liver Disease)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146815
- Sponsor's protocol ID
- Z-2022027
- Acronym
- P-CORIGA
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PolyCystic Ovary Syndrome as Suggested Risk Group for Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07146815
- Acronym / sponsor ID
- P-CORIGA / Z-2022027
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 28 Aug 2025 (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 study the prevalence, non-invasive diagnostics and evolution of non-alcoholic-fatty-liver-disease (NAFLD) in patients with polycystic ovary syndrome (PCOS)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS group | Other | Diagnostic Test: FibroScan, Diagnostic Test: MRI PDFFScreening of women with PCOS |
| Control group | Other | Diagnostic Test: FibroScan, Diagnostic Test: MRI PDFFScreening of women without PCOS |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (i.e. older than 18 years of age)
- The diagnosis of PCOS based on expert opinion (i.e. according to Rotterdam criteria)
- Able to understand patients information concerning this study
- Able to give written informed consent
Key exclusion criteria (4 listed)
- Excessive alcohol use: ≥ 2u (20g)/day for females
- Secondary causes of liver steatosis
- Other causes of endocrinological disease
- Diseases that might mimic PCOS
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 the prevalence of liver steatosis. | Diagnostic test | Control group, PCOS group |
| MRI PDFFPerformance of an MRI-PDFF to determine amount of liver steatosis. | Diagnostic test | Control group, PCOS group |
Primary outcome
Prevalence of NAFLD
Time frame: Baseline and at follow-up 1 year later.
To study the prevalence of NAFLD in a population diagnosed with PCOS measured with Controlled Attenuation Parameter (CAP)
Prevalence of NAFLD in PCOS
Time frame: Baseline
To measure the prevalence of NAFLD in women with PCOS using the MRI-PDFF technique.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and MRI PDFF in people with NAFLD (Nonalcoholic Fatty Liver Disease) and Polycystic Ovarian Syndrome (PCOS), 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of NAFLD (time frame: Baseline and at follow-up 1 year later.). 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 Aug 2025.