PolyCystic Ovary Syndrome as Suggested Risk Group for Non-Alcoholic Fatty Liver Disease

NCT ID: NCT07146815

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-29

Study Completion Date

2025-04-01

Brief Summary

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

Detailed Description

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Conditions

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NAFLD (Nonalcoholic Fatty Liver Disease) Polycystic Ovarian Syndrome (PCOS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PCOS group

Screening of women with PCOS

Group Type OTHER

FibroScan

Intervention Type DIAGNOSTIC_TEST

Performance of a FibroScan measurement to determine the prevalence of liver steatosis.

MRI PDFF

Intervention Type DIAGNOSTIC_TEST

Performance of an MRI-PDFF to determine amount of liver steatosis.

Control group

Screening of women without PCOS

Group Type OTHER

FibroScan

Intervention Type DIAGNOSTIC_TEST

Performance of a FibroScan measurement to determine the prevalence of liver steatosis.

MRI PDFF

Intervention Type DIAGNOSTIC_TEST

Performance of an MRI-PDFF to determine amount of liver steatosis.

Interventions

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FibroScan

Performance of a FibroScan measurement to determine the prevalence of liver steatosis.

Intervention Type DIAGNOSTIC_TEST

MRI PDFF

Performance of an MRI-PDFF to determine amount of liver steatosis.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ziekenhuis Oost-Limburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Z-2022027

Identifier Type: -

Identifier Source: org_study_id

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