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Adipokines in Polycystic Ovary Syndrome

Assessment of Adipokine Concentrations and Their Association With the Metabolic Profile of Women With PCOS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06793072
Enrollment
300
Registered
2025-01-27
Start date
2025-01-20
Completion date
2027-12-31
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS, Reproductive Age

Keywords

insulin resistance, polycystic ovary syndrome, metabolic syndrome, adipokines

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTLeptin concentration in blood serum

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

DIAGNOSTIC_TESTResistin concentration in blood serum

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

DIAGNOSTIC_TESTOmentin-1 concentration in blood serum

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

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of resistin concentration in three study groupsup to 6 monthsMeasurement and comparison of mean fasting plasma resistin concentration expressed in pg/ml in three study groups
Comparison of leptin concentration three study groupsup to 6 monthsMeasurement and comparison of mean fasting plasma leptin concentration expressed in pg/ml in three study groups
Comparison of omentin-1 concentration in three study groupsup to 6 monthsMeasurement and comparison of mean fasting plasma omentin-1 concentration expressed in pg/ml in three study groups

Countries

Poland

Contacts

CONTACTIwona Gawron, Ph.D., M.D.
iwona.gawron@uj.edu.pl+48 124248570
CONTACTRobert Jach, Prof., Ph.D., M.D.
jach@cm-uj.krakow.pl+48 124248570
STUDY_CHAIRKazimierz Pityński, Prof., Ph.D., M.D.

Jagiellonian University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026