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

Completed

• Conditions: PCOS; NAFLD
• Interventions: Other: Questionnaire

• Registration Number: NCT05843955
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2015-12-01
• Study Completion: 2016-05-24
• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-04-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with Polycystic ovary syndrome (PCOS)	Questionnaire	PCOS was diagnosed according to the revised 2003 Rotterdam Consensus as the presence of at least two of the following three criteria: (i)oligomenorrhoea or anovulation; (ii)clinical and/or biochemical signs of hyperandrogenemia and (iii)polycystic ovaries on ultrasound.

Primary Outcome Measures

Name	Time	Method
Non-alcoholic fatty liver disease (NAFLD) grade	3 months	NAFLD grade was evaluated by ultrasonography.
Serum vitamin D levels	3 months	Serum vitamin D levels were measured by immunoassay analyzer.
Insulin resistance	3 months	Insulin resistance analyzed by homeostasis model assessment-insulin resistance (HOMA-IR) formulation.

Trial Locations

Locations (1)

Hacettepe University Nutrition and Dietetics Department; 🇹🇷 Ankara, Turkey