An observational study in PCOS and NAFLD, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to female participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Hacettepe University · Observational
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.
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 72 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
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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.
Exclusion Criteria:
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.
Serum vitamin D levels
Serum vitamin D levels were measured by immunoassay analyzer.
Time frame: 3 months
Insulin resistance
Insulin resistance analyzed by homeostasis model assessment-insulin resistance (HOMA-IR) formulation.
Time frame: 3 months
Non-alcoholic fatty liver disease (NAFLD) grade
NAFLD grade was evaluated by ultrasonography.
Time frame: 3 months
Plan to share: No — The data are not publicly available due to ethical concerns.
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Hacettepe University