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

NCT05843955 | Completed

• 1 other identifier: GO 15/547
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS; NAFLD

Keywords

polycystic ovary syndrome; non-alcoholic fatty liver disease; obesity; insulin resistance

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Questionnaire OTHER

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

Women with Polycystic ovary syndrome (PCOS)

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Nutrition and Dietetics Department

Ankara, 06100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Polycystic Ovary Syndrome; Obesity; Insulin Resistance

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Zeynep Goktas, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: May 24, 2016
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)