Clinical trial NCT06793072: Adipokines in Polycystic Ovary Syndrome
Official title: Assessment of Adipokine Concentrations and Their Association With the Metabolic Profile of Women With PCOS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PCOS
Reproductive Age
Keywords: insulin resistance
polycystic ovary syndrome
metabolic syndrome
adipokines
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 300
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 routine check-up

Brief summary: The aim of the study is to compare the concentrations of leptin, resistin, and omentin-1 in women across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

Detailed description: Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy among reproductive-age women, characterized primarily by insulin resistance (IR), which has a prevalence of 35% to 80%. Metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The hyperinsulinemic-euglycemic clamp study is regarded as the gold standard for assessing insulin sensitivity; however, its clinical application is limited. Alternative assessments, such as the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin or glucose tolerance tests, provide limited clinical utility. Therefore, there is a pressing need for the identification of more precise and universal markers of insulin resistance. There is a need to elucidate the precise role of adipokines in the etiology of PCOS and their association with insulin resistance, which is responsible for the development of adverse health-related complications.

The aim of the study is to measure and compare the concentrations of selected adipokines: leptin, resistin, omentin-1 across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

The tests will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer.

The concentrations of the investigated substances will be measured and compared within the three research groups.

Statistical analysis will be conducted using SPSS Statistics software.

Eligibility criteria: Inclusion Criteria:

* Age 18-45

Exclusion Criteria:

* previous 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(Edited)Restore original

Primary outcomes:
measure: Comparison of resistin concentration in three study groups
timeFrame: up to 6 months
measure: Comparison of leptin concentration three study groups
timeFrame: up to 6 months
measure: Comparison of omentin-1 concentration in three study groups
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian Univeristy
Study officials:
affiliation: Jagiellonian University
name: Kazimierz Pityński, Prof., Ph.D., M.D.
role: STUDY_CHAIR
References: