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NCT Number: NCT06793072

Adipokines in Polycystic Ovary Syndrome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leptin concentration in blood serum

Diagnostic Test

Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms

Resistin concentration in blood serum

Diagnostic Test

Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms

Omentin-1 concentration in blood serum

Diagnostic Test

Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms

Primary outcomes

  1. Comparison of resistin concentration in three study groups

    Time frame: up to 6 months

    Measurement and comparison of mean fasting plasma resistin concentration expressed in pg/ml in three study groups

  2. Comparison of leptin concentration three study groups

    Time frame: up to 6 months

    Measurement and comparison of mean fasting plasma leptin concentration expressed in pg/ml in three study groups

  3. Comparison of omentin-1 concentration in three study groups

    Time frame: up to 6 months

    Measurement and comparison of mean fasting plasma omentin-1 concentration expressed in pg/ml in three study groups

Study contacts

Contact information is provided by the study sponsor or research team.

Iwona Gawron, Ph.D., M.D.

CONTACT

[email protected]

+48 124248570

Robert Jach, Prof., Ph.D., M.D.

CONTACT

[email protected]

+48 124248570

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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