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Recruiting NCT06793072

Adipokines in Polycystic Ovary Syndrome

— Observational PCOS Reproductive Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Leptin concentration in blood serum, Resistin concentration in blood serum, Omentin-1 concentration in blood serum.
Who it may be relevant to
Registry conditions: PCOS, Reproductive Age. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 test Leptin concentration in blood serum
    Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms
  • Diagnostic test Resistin concentration in blood serum
    Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms
  • 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

Primary outcome measures

  • Comparison of resistin concentration in three study groups [Time frame: up to 6 months]
  • Comparison of leptin concentration three study groups [Time frame: up to 6 months]
  • Comparison of omentin-1 concentration in three study groups [Time frame: up to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Jagiellonian Univeristy — Krakow

Identifiers

NCT: NCT06793072 · 1072.6120.44.2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗