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NCT Number: NCT06793098

Functional Proteins in Polycystic Ovary Syndrome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of kisspeptin concentration

Diagnostic Test

Measurement of kisspeptin concentration in fasting venous blood serum

Measurement of ghrelin concentration

Diagnostic Test

Measurement of ghrelin concentration in fasting venous blood serum

Measurement of zonulin concentration

Diagnostic Test

Measurement of zonulin concentration in fasting venous blood serum

Primary outcomes

  1. Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups

    Time frame: up to 6 months

  2. Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groups

    Time frame: up to 6 months

  3. Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups

    Time frame: up to 6 moths

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+48 124248570

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

CONTACT

[email protected]

+48 124248570

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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