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Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS
The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women of reproductive age, which, in addition to menstrual disorders and infertility due to anovulation, is characterized by insulin resistance (IR). The metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The severity of IR in women with PCOS is linked to abdominal obesity. There is an urgent need to identify more precise and universal markers of insulin resistance than the HOMA-IR index or glucose tolerance tests, which are intended to identify existing disorders rather than predispositions. Additionally, there is a need to investigate the balance of pro-inflammatory and anti-inflammatory parameters in PCOS and their relationship with insulin resistance, which is responsible for the development of adverse health complications. The objective of this study is to measure and compare the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, and the anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group). Tests will be conducted using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. The concentrations of the substances under investigation will be measured and compared among the three study groups. Statistical analysis will be performed using SPSS Statistics software.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
Yes
Jagiellonian University
Krakow, Poland
Start Date
January 20, 2025
Primary Completion Date
June 30, 2026
Completion Date
December 31, 2026
Last Updated
March 18, 2026
100
ESTIMATED participants
Measurement of interleukin-6 (il-6) concentration in blood serum
DIAGNOSTIC_TEST
Measurement of fasting tumor necrosis factor α (TNF-α) concentration
DIAGNOSTIC_TEST
Measurement of interleukin-18 (il-18) concentration
DIAGNOSTIC_TEST
Measurement of interleukin-4 (il-4) concentration
DIAGNOSTIC_TEST
Lead Sponsor
Jagiellonian University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07159880