Adipokines in Polycystic Ovary Syndrome

Recruiting

• Conditions: PCOS; Reproductive Age

• Registration Number: NCT06793072
• Lead Sponsor: Jagiellonian University

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.

Study Timeline

• Study Start: 2025-01-20
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of resistin concentration in three study groups	up to 6 months	Measurement and comparison of mean fasting plasma resistin concentration expressed in pg/ml in three study groups
Comparison of leptin concentration three study groups	up to 6 months	Measurement and comparison of mean fasting plasma leptin concentration expressed in pg/ml in three study groups
Comparison of omentin-1 concentration in three study groups	up to 6 months	Measurement and comparison of mean fasting plasma omentin-1 concentration expressed in pg/ml in three study groups

Trial Locations

Locations (1)

Jagiellonian Univeristy; 🇵🇱 Krakow, Poland