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

• Sponsor: Hacettepe University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05843955
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Actual Duration (Months): 8.7
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PCOS; NAFLD	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 Design

• Study Type: Observational
• Actual Enrollment: 72 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Assessment of Non-alcoholic Fatty Liver Disease and Risk Factors in Women With Polycystic Ovary Syndrome
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: May 24, 2016

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Serum vitamin D levels [3 months]

   Serum vitamin D levels were measured by immunoassay analyzer.

2. Insulin resistance [3 months]

   Insulin resistance analyzed by homeostasis model assessment-insulin resistance (HOMA-IR) formulation.

3. Non-alcoholic fatty liver disease (NAFLD) grade [3 months]

   NAFLD grade was evaluated by ultrasonography.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University Nutrition and Dietetics Department	Ankara		Turkey	06100

Sponsors and Collaborators

• Hacettepe University

Investigators

• Principal Investigator: Zeynep Goktas, PhD, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zeynep Goktas, Principal Investigator, Hacettepe University
• ClinicalTrials.gov Identifier: NCT05843955
• Other Study ID Numbers: GO 15/547
• First Posted: May 6, 2023
• Last Update Posted: May 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zeynep Goktas, Principal Investigator, Hacettepe University: polycystic ovary syndrome; non-alcoholic fatty liver disease; obesity; insulin resistance
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of May 9, 2023