Clinical trial NCT06793098: Functional Proteins in Polycystic Ovary Syndrome
Official title: Assessment of the Concentrations of Functional Proteins as Potential Early Markers of Insulin Resistance in Women With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Reproductive Age
PCOS (Polycystic Ovary Syndrome)
Keywords: insulin resistance
kisspeptin
ghrelin
zonulin
metabolic syndrome
Polycystic Ovary Syndrome
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women aged 18-45 years managed for menstrual irregularities or for routine check-up

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* women aged 18-45 years

Exclusion Criteria:

* removal of at least one ovary
* treated diabetes of any type
* diagnosed and treated metabolic diseases
* diagnosed and treated autoimmune diseases
* diagnosed and treated autoinflammatory diseases

Primary outcomes:
measure: Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups
timeFrame: up to 6 months
measure: Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groups
timeFrame: up to 6 months
measure: Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups
timeFrame: up to 6 moths
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University
Study officials:
affiliation: Jagiellonian University
name: Kazimierz Pityński, Prof., Ph.D., M.D.
role: STUDY_CHAIR
References: