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RecruitingNCT06793098Updated Mar 18, 2026

Functional Proteins in Polycystic Ovary Syndrome

An observational study in Reproductive Age and PCOS (Polycystic Ovary Syndrome), sponsored by Jagiellonian University. Recruiting at 1 site in Poland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Jagiellonian University · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Reproductive Age
  • PCOS (Polycystic Ovary Syndrome)

Keywords

  • insulin resistance
  • kisspeptin
  • ghrelin
  • zonulin
  • metabolic syndrome
  • Polycystic Ovary Syndrome
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 173 are open to participants now.

This study's planned enrollment of 100 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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

Inclusion criteria

  • women aged 18-45 years

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)

    Diagnostic Test: Measurement of kisspeptin concentration · Diagnostic Test: Measurement of ghrelin concentration · Diagnostic Test: Measurement of zonulin concentration

  • Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR)

    Diagnostic Test: Measurement of kisspeptin concentration · Diagnostic Test: Measurement of ghrelin concentration · Diagnostic Test: Measurement of zonulin concentration

  • Women without PCOS

    Diagnostic Test: Measurement of kisspeptin concentration · Diagnostic Test: Measurement of ghrelin concentration · Diagnostic Test: Measurement of zonulin concentration

Interventions

  • Diagnostic testMeasurement of kisspeptin concentration

    Measurement of kisspeptin concentration in fasting venous blood serum

  • Diagnostic testMeasurement of ghrelin concentration

    Measurement of ghrelin concentration in fasting venous blood serum

  • Diagnostic testMeasurement of zonulin concentration

    Measurement of zonulin concentration in fasting venous blood serum

06

What researchers measure

Primary outcomes

  1. Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups

    Time frame: up to 6 months

  2. Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groups

    Time frame: up to 6 months

  3. Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups

    Time frame: up to 6 moths

07

Study locations

1 of 1 sites recruiting
  • Jagiellonian University
    Krakow, Poland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06793098
Lead sponsor
Jagiellonian University
Responsible party
Iwona Magdalena Gawron (PhD, MD, Principal Investigator, Jagiellonian University) — Principal investigator
First posted
Jan 27, 2025
Start date
Jan 20, 2025
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 18, 2026

Study contacts

Iwona Gawron, Ph.D., M.D.
Contact
iwona.gawron@uj.edu.pl
+48 124248570
Robert Jach, Prof., Ph.D., M.D.
Contact
jach@cm-uj.krakow.pl
+48 124248570
Kazimierz Pityński, Prof., Ph.D., M.D.
study chair · Jagiellonian University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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