Adipokines in Polycystic Ovary Syndrome

NCT ID: NCT06793072

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-20

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

PCOS Reproductive Age

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PCOS+IR

Polycystic ovary syndrome + insulin resistance

Leptin concentration in blood serum

Intervention Type DIAGNOSTIC_TEST

Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms

Resistin concentration in blood serum

Intervention Type DIAGNOSTIC_TEST

Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms

Omentin-1 concentration in blood serum

Intervention Type DIAGNOSTIC_TEST

Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms

PCOS + no IR

Polycystic ovary syndrome + no insulin resistance

Leptin concentration in blood serum

Intervention Type DIAGNOSTIC_TEST

Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms

Resistin concentration in blood serum

Intervention Type DIAGNOSTIC_TEST

Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms

Omentin-1 concentration in blood serum

Intervention Type DIAGNOSTIC_TEST

Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms

No PCOS

Women without PCOS (control)

Leptin concentration in blood serum

Intervention Type DIAGNOSTIC_TEST

Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms

Resistin concentration in blood serum

Intervention Type DIAGNOSTIC_TEST

Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms

Omentin-1 concentration in blood serum

Intervention Type DIAGNOSTIC_TEST

Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Leptin concentration in blood serum

Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms

Intervention Type DIAGNOSTIC_TEST

Resistin concentration in blood serum

Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms

Intervention Type DIAGNOSTIC_TEST

Omentin-1 concentration in blood serum

Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-45

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Iwona Magdalena Gawron

PhD, MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kazimierz PityƄski, Prof., Ph.D., M.D.

Role: STUDY_CHAIR

Jagiellonian University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jagiellonian Univeristy

Krakow, , Poland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

+48 124248570

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

Role: CONTACT

+48 124248570

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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

Role: primary

+48 124248570

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1072.6120.44.2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.