NAFLD (Nonalcoholic Fatty Liver Disease), Polycystic Ovarian Syndrome (PCOS)
Conditions
Brief summary
To study the prevalence, non-invasive diagnostics and evolution of non-alcoholic-fatty-liver-disease (NAFLD) in patients with polycystic ovary syndrome (PCOS)
Interventions
DIAGNOSTIC_TESTFibroScan
Performance of a FibroScan measurement to determine the prevalence of liver steatosis.
DIAGNOSTIC_TESTMRI PDFF
Performance of an MRI-PDFF to determine amount of liver steatosis.
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Excessive alcohol use: ≥ 2u (20g)/day for females * Exclusion of other causes of liver disease * Secondary causes of liver steatosis * Other causes of endocrinological disease * Diseases that might mimic PCOS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of NAFLD | 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 | Baseline | To measure the prevalence of NAFLD in women with PCOS using the MRI-PDFF technique. |
Countries
Belgium
Outcome results
None listed