Functional Proteins in Polycystic Ovary Syndrome

NCT ID: NCT06793098

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Reproductive Age PCOS (Polycystic Ovary Syndrome)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)

Measurement of kisspeptin concentration

Intervention Type DIAGNOSTIC_TEST

Measurement of kisspeptin concentration in fasting venous blood serum

Measurement of ghrelin concentration

Intervention Type DIAGNOSTIC_TEST

Measurement of ghrelin concentration in fasting venous blood serum

Measurement of zonulin concentration

Intervention Type DIAGNOSTIC_TEST

Measurement of zonulin concentration in fasting venous blood serum

Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR)

Measurement of kisspeptin concentration

Intervention Type DIAGNOSTIC_TEST

Measurement of kisspeptin concentration in fasting venous blood serum

Measurement of ghrelin concentration

Intervention Type DIAGNOSTIC_TEST

Measurement of ghrelin concentration in fasting venous blood serum

Measurement of zonulin concentration

Intervention Type DIAGNOSTIC_TEST

Measurement of zonulin concentration in fasting venous blood serum

Women without PCOS

Measurement of kisspeptin concentration

Intervention Type DIAGNOSTIC_TEST

Measurement of kisspeptin concentration in fasting venous blood serum

Measurement of ghrelin concentration

Intervention Type DIAGNOSTIC_TEST

Measurement of ghrelin concentration in fasting venous blood serum

Measurement of zonulin concentration

Intervention Type DIAGNOSTIC_TEST

Measurement of zonulin concentration in fasting venous blood serum

Interventions

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Measurement of kisspeptin concentration

Measurement of kisspeptin concentration in fasting venous blood serum

Intervention Type DIAGNOSTIC_TEST

Measurement of ghrelin concentration

Measurement of ghrelin concentration in fasting venous blood serum

Intervention Type DIAGNOSTIC_TEST

Measurement of zonulin concentration

Measurement of zonulin concentration in fasting venous blood serum

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Iwona Magdalena Gawron

PhD, MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kazimierz PityƄski, Prof., Ph.D., M.D.

Role: STUDY_CHAIR

Jagiellonian University

Locations

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Jagiellonian University

Krakow, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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

Role: CONTACT

+48 124248570

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

Role: CONTACT

+48 124248570

Other Identifiers

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1072.6120.44.2024-3

Identifier Type: -

Identifier Source: org_study_id

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