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Adipokines in Polycystic Ovary Syndrome

J

Jagiellonian University

Status

Enrolling

Conditions

PCOS
Reproductive Age

Treatments

Diagnostic Test: Leptin concentration in blood serum
Diagnostic Test: Resistin concentration in blood serum
Diagnostic Test: Omentin-1 concentration in blood serum

Study type

Observational

Funder types

Other

Identifiers

NCT06793072
1072.6120.44.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

PCOS+IR
Description:
Polycystic ovary syndrome + insulin resistance
Treatment:
Diagnostic Test: Omentin-1 concentration in blood serum
Diagnostic Test: Resistin concentration in blood serum
Diagnostic Test: Leptin concentration in blood serum
PCOS + no IR
Description:
Polycystic ovary syndrome + no insulin resistance
Treatment:
Diagnostic Test: Omentin-1 concentration in blood serum
Diagnostic Test: Resistin concentration in blood serum
Diagnostic Test: Leptin concentration in blood serum
No PCOS
Description:
Women without PCOS (control)
Treatment:
Diagnostic Test: Omentin-1 concentration in blood serum
Diagnostic Test: Resistin concentration in blood serum
Diagnostic Test: Leptin concentration in blood serum

Trial contacts and locations

1

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Central trial contact

Robert Jach, Prof., Ph.D., M.D.; Iwona Gawron, Ph.D., M.D.

Data sourced from clinicaltrials.gov

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