Functional Proteins in Polycystic Ovary Syndrome

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

Assessment of the Concentrations of Functional Proteins as Potential Early Markers of Insulin Resistance in Women With Polycystic Ovary Syndrome

The concentration of functional proteins: kisspeptin, ghrelin, zonulin will be measured and compared in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), in women with PCOS without IR, and in women without PCOS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Polycystic Ovary Syndrome (PCOS) is currently the most common endocrine disorder in women of reproductive age with an unknown etiology. A predominant metabolic feature of PCOS is insulin resistance (IR), which contributes to the pathogenesis and expression of other symptoms of the syndrome, such as hyperandrogenism. The metabolic disturbances in women with PCOS result in a higher incidence of cardiovascular diseases and endometrial cancer in the premenopausal age. The gold standard for assessing peripheral tissue sensitivity to insulin is the hyperinsulinemic-euglycemic clamp technique; however, this method is not commonly used in clinical practice due to its complexities. Instead, simpler tests, such as the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin measurements along with glucose tolerance tests, are employed. These methods are utilized for diagnosing insulin resistance rather than identifying predispositions. Therefore, there is an urgent need to identify more precise markers of IR that could be used in routine early-stage assessments. Given the long-term complications associated with PCOS, which can shorten life expectancy, early diagnosis and treatment of IR are crucial. Furthermore, such studies may contribute to exploring the etiopathogenesis of the syndrome. The discovery of "markers" that can predict or diagnose metabolic abnormalities at an early stage, prior to the onset of clinical symptoms, would facilitate early intervention and treatment, thus preventing a decline in quality of life associated with PCOS.

This study will measure and compare the concentrations of locally acting hormones: ghrelin, kisspeptin, and zonulin in three research groups: women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), women with PCOS without IR, and women without PCOS. Measurements will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. Statistical calculations will be conducted using SPSS Statistics software.

Study Type

Observational

Enrollment (Estimated)

100

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 University

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 for routine check-up

Description

Inclusion Criteria:

  • women aged 18-45 years

Exclusion Criteria:

  • 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

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
Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)
Diagnostic test: Measurement of kisspeptin concentration
Measurement of kisspeptin concentration in fasting venous blood serum
Diagnostic test: Measurement of ghrelin concentration
Measurement of ghrelin concentration in fasting venous blood serum
Diagnostic test: Measurement of zonulin concentration
Measurement of zonulin concentration in fasting venous blood serum
Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR)
Diagnostic test: Measurement of kisspeptin concentration
Measurement of kisspeptin concentration in fasting venous blood serum
Diagnostic test: Measurement of ghrelin concentration
Measurement of ghrelin concentration in fasting venous blood serum
Diagnostic test: Measurement of zonulin concentration
Measurement of zonulin concentration in fasting venous blood serum
Women without PCOS
Diagnostic test: Measurement of kisspeptin concentration
Measurement of kisspeptin concentration in fasting venous blood serum
Diagnostic test: Measurement of ghrelin concentration
Measurement of ghrelin concentration in fasting venous blood serum
Diagnostic test: Measurement of zonulin concentration
Measurement of zonulin concentration in fasting venous blood serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups
Time Frame: up to 6 months
up to 6 months
Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groups
Time Frame: up to 6 months
up to 6 months
Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups
Time Frame: up to 6 moths
up to 6 moths

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 1, 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

  • 1072.6120.44.2024-3

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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