PCOSNCT06793072
Adipokines in Polycystic Ovary Syndrome
An observational study of PCOS and Reproductive Age, run by Jagiellonian University at 1 site in Poland.
Trial summary
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. 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
- PCOS, Reproductive Age
- What is being tested?
- Leptin concentration in blood serum, Resistin concentration in blood serum and Omentin-1 concentration in blood serum
- How many people
- 300 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 routine check-up
Who may be able to join
- Age 18-45
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian Univeristy
Krakow
Iwona Gawron, Ph.D., M.D., +48 124248570, iwona.gawron@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- PCOS, Reproductive Age
- Being tested
- Leptin concentration in blood serum, Resistin concentration in blood serum, Omentin-1 concentration in blood serum
- Keywords
- insulin resistance, polycystic ovary syndrome, metabolic syndrome, adipokines
- Medical subject headings
- Insulin Resistance, Polycystic Ovary Syndrome, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leptin concentration in blood serumDiagnostic test
Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms
Resistin concentration in blood serumDiagnostic test
Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms
Omentin-1 concentration in blood serumDiagnostic test
Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms
| Study group | Role | What they receive |
|---|---|---|
| PCOS+IR | Polycystic ovary syndrome + insulin resistance Receives: Diagnostic Test: Leptin concentration in blood serum; Diagnostic Test: Resistin concentration in blood serum; Diagnostic Test: Omentin-1 concentration in blood serum | |
| PCOS + no IR | Polycystic ovary syndrome + no insulin resistance Receives: Diagnostic Test: Leptin concentration in blood serum; Diagnostic Test: Resistin concentration in blood serum; Diagnostic Test: Omentin-1 concentration in blood serum | |
| No PCOS | Women without PCOS (control) Receives: Diagnostic Test: Leptin concentration in blood serum; Diagnostic Test: Resistin concentration in blood serum; Diagnostic Test: Omentin-1 concentration in blood serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of resistin concentration in three study groups
Measurement and comparison of mean fasting plasma resistin concentration expressed in pg/ml in three study groups
Measured: up to 6 months
Comparison of leptin concentration three study groups
Measurement and comparison of mean fasting plasma leptin concentration expressed in pg/ml in three study groups
Measured: up to 6 months
Comparison of omentin-1 concentration in three study groups
Measurement and comparison of mean fasting plasma omentin-1 concentration expressed in pg/ml in three study groups
Measured: up to 6 months
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 completion31 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 PCOSStudies 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
- 300 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
- NCT06793072
- Sponsor's protocol ID
- 1072.6120.44.2024
- 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 Adipokine Concentrations and Their Association With the Metabolic Profile of Women With PCOS
- ClinicalTrials.gov ID
- NCT06793072
- Acronym / sponsor ID
- 1072.6120.44.2024
- Conditions
- PCOS, Reproductive Age
- Keywords
- insulin resistance, polycystic ovary syndrome, metabolic syndrome, adipokines
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCOS+IR | – | Diagnostic Test: Leptin concentration in blood serum, Diagnostic Test: Resistin concentration in blood serum, Diagnostic Test: Omentin-1 concentration in blood serumPolycystic ovary syndrome + insulin resistance |
| PCOS + no IR | – | Diagnostic Test: Leptin concentration in blood serum, Diagnostic Test: Resistin concentration in blood serum, Diagnostic Test: Omentin-1 concentration in blood serumPolycystic ovary syndrome + no insulin resistance |
| No PCOS | – | Diagnostic Test: Leptin concentration in blood serum, Diagnostic Test: Resistin concentration in blood serum, Diagnostic Test: Omentin-1 concentration in blood serumWomen without PCOS (control) |
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 routine check-up
Key inclusion criteria (1 listed)
- Age 18-45
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Leptin concentration in blood serumFasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms | Diagnostic test | No PCOS, PCOS + no IR, PCOS+IR |
| Resistin concentration in blood serumFasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms | Diagnostic test | No PCOS, PCOS + no IR, PCOS+IR |
| Omentin-1 concentration in blood serumFasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms | Diagnostic test | No PCOS, PCOS + no IR, PCOS+IR |
Primary outcome
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
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
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
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.
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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 PCOS and Reproductive Age, 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?
Comparison of resistin concentration in 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.