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Functional Proteins in Polycystic Ovary Syndrome

J

Jagiellonian University

Status

Enrolling

Conditions

Reproductive Age
PCOS (Polycystic Ovary Syndrome)

Treatments

Diagnostic Test: Measurement of ghrelin concentration
Diagnostic Test: Measurement of kisspeptin concentration
Diagnostic Test: Measurement of zonulin concentration

Study type

Observational

Funder types

Other

Identifiers

NCT06793098
1072.6120.44.2024-3

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)
Treatment:
Diagnostic Test: Measurement of zonulin concentration
Diagnostic Test: Measurement of kisspeptin concentration
Diagnostic Test: Measurement of ghrelin concentration
Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR)
Treatment:
Diagnostic Test: Measurement of zonulin concentration
Diagnostic Test: Measurement of kisspeptin concentration
Diagnostic Test: Measurement of ghrelin concentration
Women without PCOS
Treatment:
Diagnostic Test: Measurement of zonulin concentration
Diagnostic Test: Measurement of kisspeptin concentration
Diagnostic Test: Measurement of ghrelin concentration

Trial contacts and locations

1

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Central trial contact

Robert Jach, Prof., Ph.D., M.D.; Iwona Gawron, Ph.D., M.D.

Data sourced from clinicaltrials.gov

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