Reproductive AgeNCT06793098
Functional Proteins in Polycystic Ovary Syndrome
An observational study of Reproductive Age and PCOS (Polycystic Ovary Syndrome), run by Jagiellonian University at 1 site in Poland.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Age, PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Measurement of kisspeptin concentration, Measurement of ghrelin concentration and Measurement of zonulin concentration
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jan 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women aged 18-45 years managed for menstrual irregularities or for routine check-up
Who may be able to join
- women aged 18-45 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Reproductive Age, PCOS (Polycystic Ovary Syndrome)
- Being tested
- Measurement of kisspeptin concentration, Measurement of ghrelin concentration, Measurement of zonulin concentration
- Keywords
- insulin resistance, kisspeptin, ghrelin, zonulin, metabolic syndrome, Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of kisspeptin concentrationDiagnostic test
Measurement of kisspeptin concentration in fasting venous blood serum
Measurement of ghrelin concentrationDiagnostic test
Measurement of ghrelin concentration in fasting venous blood serum
Measurement of zonulin concentrationDiagnostic test
Measurement of zonulin concentration in fasting venous blood serum
| Study group | Role | What they receive |
|---|---|---|
| Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR) | Not described Receives: 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) | Not described Receives: Diagnostic Test: Measurement of kisspeptin concentration; Diagnostic Test: Measurement of ghrelin concentration; Diagnostic Test: Measurement of zonulin concentration | |
| Women without PCOS | Not described Receives: Diagnostic Test: Measurement of kisspeptin concentration; Diagnostic Test: Measurement of ghrelin concentration; Diagnostic Test: Measurement of zonulin concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups
Measured: up to 6 months
Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groups
Measured: up to 6 months
Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups
Measured: up to 6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start20 Jan 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Kazimierz Pityński, Prof., Ph.D., M.D., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793098
- Sponsor's protocol ID
- 1072.6120.44.2024-3
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Concentrations of Functional Proteins as Potential Early Markers of Insulin Resistance in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06793098
- Acronym / sponsor ID
- 1072.6120.44.2024-3
- Conditions
- Reproductive Age, PCOS (Polycystic Ovary Syndrome)
- Keywords
- insulin resistance, kisspeptin, ghrelin, zonulin, metabolic syndrome, Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women aged 18-45 years managed for menstrual irregularities or for routine check-up
Key inclusion criteria (1 listed)
- women aged 18-45 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of kisspeptin concentrationMeasurement of kisspeptin concentration in fasting venous blood serum | Diagnostic test | 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 concentrationMeasurement of ghrelin concentration in fasting venous blood serum | Diagnostic test | 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 concentrationMeasurement of zonulin concentration in fasting venous blood serum | Diagnostic test | Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR), Women without PCOS |
Primary outcome
Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups
Time frame: 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
Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups
Time frame: up to 6 moths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Reproductive Age
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Active, not recruitingObservational study
Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Active, not recruiting
Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes
Diabetes Mellitus, Type 2, Electronic Health Record
Recruiting
Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age
Male Infertility, Advanced Paternal Age
Not yet recruiting
Reducing Endocrine-Disrupting Chemical Exposure in Reproductive-Age Women: A Pender Model-Based RCT
Women Who Are Aged 18-49 Years, Able to Read, Write
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kazimierz Pityński, Prof., Ph.D., M.D. study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Age and PCOS (Polycystic Ovary Syndrome), run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iwona Gawron, Ph.D., M.D. (+48 124248570, iwona.gawron@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.