Adipokines in Polycystic Ovary Syndrome

March 17, 2026 updated by: Iwona Magdalena Gawron, Jagiellonian University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Krakow, Poland
        • Recruiting
        • Jagiellonian Univeristy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

women aged 18-45 years managed for menstrual irregularities or routine check-up

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCOS+IR
Polycystic ovary syndrome + insulin resistance
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
PCOS + no IR
Polycystic ovary syndrome + no insulin resistance
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
No PCOS
Women without PCOS (control)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 6 months
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
up to 6 months
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
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Study Chair: Kazimierz Pityński, Prof., Ph.D., M.D., Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.44.2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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