PolyCystic Ovary Syndrome as Suggested Risk Group for Non-Alcoholic Fatty Liver Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 157
- Locations
- 1
- Primary Endpoint
- Prevalence of NAFLD
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
PCOS group
Screening of women with PCOS
Intervention: FibroScan (Diagnostic Test)
Control group
Screening of women without PCOS
Intervention: FibroScan (Diagnostic Test)
Control group
Screening of women without PCOS
Intervention: MRI PDFF (Diagnostic Test)
PCOS group
Screening of women with PCOS
Intervention: MRI PDFF (Diagnostic Test)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported