NCT06793072

Adipokines in Polycystic Ovary Syndrome

Assessment of Adipokine Concentrations and Their Association With the Metabolic Profile of Women With PCOS

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• PCOS
• Reproductive Age

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Leptin concentration in blood serum	Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms
DIAGNOSTIC_TEST	Resistin concentration in blood serum	Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms
DIAGNOSTIC_TEST	Omentin-1 concentration in blood serum	Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms

Timeline

• Start date: 2025-01-20
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-01-27
• Last updated: 2026-03-18

Locations

1 site across 1 country: Poland