PolyCystic Ovary Syndrome as Suggested Risk Group for Non-Alcoholic Fatty Liver Disease (P-CORIGA)

East Limburg Hospital

Status: Completed

Conditions: NAFLD (Nonalcoholic Fatty Liver Disease); Polycystic Ovarian Syndrome (PCOS)

Treatments: Diagnostic Test: MRI PDFF; Diagnostic Test: FibroScan

Study type: Interventional

Funder types: Other

Identifiers

NCT07146815

Z-2022027

Details and patient eligibility

About

To study the prevalence, non-invasive diagnostics and evolution of non-alcoholic-fatty-liver-disease (NAFLD) in patients with polycystic ovary syndrome (PCOS)

Enrollment: 157 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 2 patient groups

PCOS group

Other group

Description:

Screening of women with PCOS

Treatment:

Diagnostic Test: FibroScan

Diagnostic Test: MRI PDFF

Control group

Other group

Description:

Screening of women without PCOS

Treatment:

Diagnostic Test: FibroScan

Diagnostic Test: MRI PDFF