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Recruiting NCT06793098

Functional Proteins in Polycystic Ovary Syndrome

Observational Reproductive Age PCOS (Polycystic Ovary Syndrome)

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: Measurement of kisspeptin concentration, Measurement of ghrelin concentration, Measurement of zonulin concentration.
Who it may be relevant to
Registry conditions: Reproductive Age, PCOS (Polycystic Ovary Syndrome). 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 →
Official title

Assessment of the Concentrations of Functional Proteins as Potential Early Markers of Insulin Resistance in Women With Polycystic Ovary Syndrome

Overview

The concentration of functional proteins: kisspeptin, ghrelin, zonulin will be measured and compared in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), in women with PCOS without IR, and in women without PCOS.

Detailed description

Polycystic Ovary Syndrome (PCOS) is currently the most common endocrine disorder in women of reproductive age with an unknown etiology. A predominant metabolic feature of PCOS is insulin resistance (IR), which contributes to the pathogenesis and expression of other symptoms of the syndrome, such as hyperandrogenism. The metabolic disturbances in women with PCOS result in a higher incidence of cardiovascular diseases and endometrial cancer in the premenopausal age. The gold standard for assessing peripheral tissue sensitivity to insulin is the hyperinsulinemic-euglycemic clamp technique; however, this method is not commonly used in clinical practice due to its complexities. Instead, simpler tests, such as the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin measurements along with glucose tolerance tests, are employed. These methods are utilized for diagnosing insulin resistance rather than identifying predispositions. Therefore, there is an urgent need to identify more precise markers of IR that could be used in routine early-stage assessments. Given the long-term complications associated with PCOS, which can shorten life expectancy, early diagnosis and treatment of IR are crucial. Furthermore, such studies may contribute to exploring the etiopathogenesis of the syndrome. The discovery of "markers" that can predict or diagnose metabolic abnormalities at an early stage, prior to the onset of clinical symptoms, would facilitate early intervention and treatment, thus preventing a decline in quality of life associated with PCOS.

This study will measure and compare the concentrations of locally acting hormones: ghrelin, kisspeptin, and zonulin in three research groups: women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), women with PCOS without IR, and women without PCOS. Measurements will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. Statistical calculations will be conducted using SPSS Statistics software.

Interventions

  • Diagnostic test Measurement of kisspeptin concentration
    Measurement of kisspeptin concentration in fasting venous blood serum
  • Diagnostic test Measurement of ghrelin concentration
    Measurement of ghrelin concentration in fasting venous blood serum
  • Diagnostic test Measurement of zonulin concentration
    Measurement of zonulin concentration in fasting venous blood serum

Primary outcome measures

  • Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups [Time frame: up to 6 months]
  • Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groups [Time frame: up to 6 months]
  • Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups [Time frame: up to 6 moths]

Eligibility criteria

Inclusion criteria

  • women aged 18-45 years

Exclusion criteria

  • 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

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 University — Krakow

Identifiers

NCT: NCT06793098 · 1072.6120.44.2024-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗