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

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05843955
• Other study ID #: GO 15/547
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: May 24, 2016

Study information

• Verified date: May 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 24, 2016
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• PCOS
• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University Nutrition and Dietetics Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

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