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Non-alcoholic Fatty Liver Disease in Women With Polycystic Ovary Syndrome

Assessment of Non-alcoholic Fatty Liver Disease and Risk Factors in Women With Polycystic Ovary Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05843955
Enrollment
72
Registered
2023-05-06
Start date
2015-09-01
Completion date
2016-05-24
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD, PCOS

Keywords

polycystic ovary syndrome, non-alcoholic fatty liver disease, obesity, insulin resistance

Brief summary

This study was planned to examine the prevalence of vitamin D insufficiency, insulin resistance, non-alcoholic fatty liver disease (NAFLD), and their relationship with each other and the nutritional status of individuals with polycystic ovary syndrome (PCOS) in reproductive age, by evaluating anthropometric, biochemical, and ultrasonographic findings and food consumption frequency data.

Detailed description

A total of 72 female individuals diagnosed with PCOS were included in the study. Nutritional status, physical activity levels, anthropometric measurements, and biochemical parameters of individuals were examined. A food consumption frequency questionnaire was applied to the individuals. According to the 2003 Rotterdam Consensus revision, PCOS is diagnosed when at least two of the following three conditions are present: Polycystic ovaries on ultrasonography, oligomenorrhoea, or anovulation; clinical and/or biochemical symptoms of hyperandrogenemia. Testing was done on insulin, lipid profiles, fasting plasma glucose, and liver function. Bioelectrical impedance analysis was used to determine body weight and composition. An abdominal ultrasound was used to diagnose NAFLD.

Interventions

OTHERQuestionnaire

Nutritional status, physical activity levels, anthropometric measurements, and biochemical parameters of individuals were examined. A food consumption frequency questionnaire was administered.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* female sex * PCOS diagnosis * no use of oral contraceptives or any hormone therapy in the last 3 months * no use of vitamin D supplements in the last 3 months * no use of oral antidiabetic drugs in the last 3 months

Exclusion criteria

* adrenal dysfunction * diabetes mellitus * pregnancy * alcohol consumption * a history of chronic viral hepatitis * autoimmune liver disease * other liver diseases * history of hepatotoxicity * use of antihypertensive, antidiabetic, lipid-lowering drugs

Design outcomes

Primary

MeasureTime frameDescription
Serum vitamin D levels3 monthsSerum vitamin D levels were measured by immunoassay analyzer.
Insulin resistance3 monthsInsulin resistance analyzed by homeostasis model assessment-insulin resistance (HOMA-IR) formulation.
Non-alcoholic fatty liver disease (NAFLD) grade3 monthsNAFLD grade was evaluated by ultrasonography.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026