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Functional Proteins in Polycystic Ovary Syndrome

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06793098
Enrollment
100
Registered
2025-01-27
Start date
2025-01-20
Completion date
2027-12-31
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS (Polycystic Ovary Syndrome), Reproductive Age

Keywords

insulin resistance, kisspeptin, ghrelin, zonulin, metabolic syndrome, Polycystic Ovary Syndrome

Brief summary

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_TESTMeasurement of kisspeptin concentration

Measurement of kisspeptin concentration in fasting venous blood serum

DIAGNOSTIC_TESTMeasurement of ghrelin concentration

Measurement of ghrelin concentration in fasting venous blood serum

DIAGNOSTIC_TESTMeasurement of zonulin concentration

Measurement of zonulin concentration in fasting venous blood serum

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groupsup to 6 months
Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groupsup to 6 months
Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groupsup to 6 moths

Countries

Poland

Contacts

CONTACTIwona Gawron, Ph.D., M.D.
iwona.gawron@uj.edu.pl+48 124248570
CONTACTRobert Jach, Prof., Ph.D., M.D.
jach@cm-uj.krakow.pl+48 124248570
STUDY_CHAIRKazimierz Pityński, Prof., Ph.D., M.D.

Jagiellonian University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026