An observational study in Reproductive Age and PCOS (Polycystic Ovary Syndrome), sponsored by Jagiellonian University. Recruiting at 1 site in Poland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Jagiellonian University · Observational
The concentration of functional proteins: kisspeptin, ghrelin, zonulin will be measured and compared in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), in women with PCOS without IR, and in women without PCOS.
Polycystic Ovary Syndrome (PCOS) is currently the most common endocrine disorder in women of reproductive age with an unknown etiology. A predominant metabolic feature of PCOS is insulin resistance (IR), which contributes to the pathogenesis and expression of other symptoms of the syndrome, such as hyperandrogenism. The metabolic disturbances in women with PCOS result in a higher incidence of cardiovascular diseases and endometrial cancer in the premenopausal age. The gold standard for assessing peripheral tissue sensitivity to insulin is the hyperinsulinemic-euglycemic clamp technique; however, this method is not commonly used in clinical practice due to its complexities. Instead, simpler tests, such as the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin measurements along with glucose tolerance tests, are employed. These methods are utilized for diagnosing insulin resistance rather than identifying predispositions. Therefore, there is an urgent need to identify more precise markers of IR that could be used in routine early-stage assessments. Given the long-term complications associated with PCOS, which can shorten life expectancy, early diagnosis and treatment of IR are crucial. Furthermore, such studies may contribute to exploring the etiopathogenesis of the syndrome. The discovery of "markers" that can predict or diagnose metabolic abnormalities at an early stage, prior to the onset of clinical symptoms, would facilitate early intervention and treatment, thus preventing a decline in quality of life associated with PCOS.
This study will measure and compare the concentrations of locally acting hormones: ghrelin, kisspeptin, and zonulin in three research groups: women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), women with PCOS without IR, and women without PCOS. Measurements will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. Statistical calculations will be conducted using SPSS Statistics software.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 173 are open to participants now.
This study's planned enrollment of 100 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
women aged 18-45 years managed for menstrual irregularities or for routine check-up
Exclusion Criteria:
Diagnostic Test: Measurement of kisspeptin concentration · Diagnostic Test: Measurement of ghrelin concentration · Diagnostic Test: Measurement of zonulin concentration
Diagnostic Test: Measurement of kisspeptin concentration · Diagnostic Test: Measurement of ghrelin concentration · Diagnostic Test: Measurement of zonulin concentration
Diagnostic Test: Measurement of kisspeptin concentration · Diagnostic Test: Measurement of ghrelin concentration · Diagnostic Test: Measurement of zonulin concentration
Measurement of kisspeptin concentration in fasting venous blood serum
Measurement of ghrelin concentration in fasting venous blood serum
Measurement of zonulin concentration in fasting venous blood serum
Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups
Time frame: up to 6 months
Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groups
Time frame: up to 6 months
Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups
Time frame: up to 6 moths
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Jagiellonian University