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Completed

NCT Number: NCT05843955

Non-alcoholic Fatty Liver Disease 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.

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Key information

Conditions

PCOS Adnexal Diseases Body Weight Cysts Digestive System Diseases Endocrine System Diseases Fatty Liver Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases NAFLD Neoplasms Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Hacettepe University Nutrition and Dietetics Department

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. Serum vitamin D levels

    Time frame: 3 months

    Serum vitamin D levels were measured by immunoassay analyzer.

  2. Insulin resistance

    Time frame: 3 months

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

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

    Time frame: 3 months

    NAFLD grade was evaluated by ultrasonography.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 6, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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