Adipokines in Polycystic Ovary Syndrome

Last updated: February 4, 2025
Sponsor: Jagiellonian University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Leptin concentration in blood serum

Resistin concentration in blood serum

Omentin-1 concentration in blood serum

Clinical Study ID

NCT06793072
1072.6120.44.2024
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-45

Exclusion

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

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Leptin concentration in blood serum
Phase:
Study Start date:
January 20, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Jagiellonian Univeristy

    Krakow,
    Poland

    Active - Recruiting

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