NCT06793098

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

January 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

January 20, 2025

Last Update Submit

March 17, 2026

Conditions

PCOS (Polycystic Ovary Syndrome)Reproductive Age

Keywords

insulin resistancekisspeptinghrelinzonulinmetabolic syndromePolycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (3)

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

    up to 6 months

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

    up to 6 months

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

    up to 6 moths

Study Arms (3)

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

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

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

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

Women without PCOS

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

Interventions

Measurement of kisspeptin concentrationDIAGNOSTIC_TEST

Measurement of kisspeptin concentration in fasting venous blood serum

Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR)Women without PCOS
Measurement of ghrelin concentrationDIAGNOSTIC_TEST

Measurement of ghrelin concentration in fasting venous blood serum

Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR)Women without PCOS
Measurement of zonulin concentrationDIAGNOSTIC_TEST

Measurement of zonulin concentration in fasting venous blood serum

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • women aged 18-45 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University

Krakow, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum samples

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin ResistanceMetabolic Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kazimierz Pityński, Prof., Ph.D., M.D.

    Jagiellonian University

    STUDY CHAIR

Central Study Contacts

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

CONTACT

+48 124248570iwona.gawron@uj.edu.pl

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

CONTACT

+48 124248570jach@cm-uj.krakow.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD, Principal Investigator

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

January 20, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

PL(1)