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

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.

Study Overview

• Status: Completed
• Conditions: PCOS; NAFLD
• Intervention / Treatment: Other: Questionnaire

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 Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Nutrition and Dietetics Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The appropriate sample size was determined to be 65 using power analysis in accordance with the results of the prior studies, with a 90% confidence interval and a 0.05 type-I error. The Rotterdam Consensus, revised in 2003, defined polycystic ovary syndrome (PCOS) 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) ultrasound-confirmed polycystic ovaries. 328 volunteer women who visited the clinic throughout the research period were chosen as participants after being screened for eligibility. This study included 72 women who were confirmed to be eligible and ranged in age from 18 to 40.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with Polycystic ovary syndrome (PCOS); 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.	Other: Questionnaire; Nutritional status, physical activity levels, anthropometric measurements, and biochemical parameters of individuals were examined. A food consumption frequency questionnaire was administered.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Zeynep Goktas, PhD, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 24, 2016

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome; obesity; insulin resistance; non-alcoholic fatty liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Liver Diseases; Polycystic Ovary Syndrome; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: GO 15/547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data are not publicly available due to ethical concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No