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Идёт набор NCT06793085

Pro- and Anti-inflammatory Cytokines in PCOS

— Наблюдательное Reproductive Age PCOS (Polycystic Ovary Syndrome)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Measurement of interleukin-6 (il-6) concentration in blood serum, Measurement of fasting tumor necrosis factor α (TNF-α) concentration, Measurement of interleukin-18 (il-18) concentration, Measurement of interleukin-4 (il-4) concentration.
Кому может быть актуально
Состояния в реестре: Reproductive Age, PCOS (Polycystic Ovary Syndrome). Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
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Официальное название

Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS

Обзор

The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

Подробное описание

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women of reproductive age, which, in addition to menstrual disorders and infertility due to anovulation, is characterized by insulin resistance (IR). The metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The severity of IR in women with PCOS is linked to abdominal obesity. There is an urgent need to identify more precise and universal markers of insulin resistance than the HOMA-IR index or glucose tolerance tests, which are intended to identify existing disorders rather than predispositions. Additionally, there is a need to investigate the balance of pro-inflammatory and anti-inflammatory parameters in PCOS and their relationship with insulin resistance, which is responsible for the development of adverse health complications.

The objective of this study is to measure and compare the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, and the anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

Tests will be conducted using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. The concentrations of the substances under investigation will be measured and compared among the three study groups. Statistical analysis will be performed using SPSS Statistics software.

Вмешательства

  • Диагностический тест Measurement of interleukin-6 (il-6) concentration in blood serum
    Measurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum
  • Диагностический тест Measurement of fasting tumor necrosis factor α (TNF-α) concentration
    Measurement of fasting tumor necrosis factor α concentration in fasting venous blood serum
  • Диагностический тест Measurement of interleukin-18 (il-18) concentration
    Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum
  • Диагностический тест Measurement of interleukin-4 (il-4) concentration
    Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma

Первичные конечные точки

  • Il-6 concentration [Срок оценки: up to 6 months]
  • Il-18 concentration [Срок оценки: up to 6 months]
  • Il-4 concentration [Срок оценки: up to 6 months]
  • TNF-α concentration [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

  • women aged 18-45 years

Критерии исключения

  • previous 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Польша · 1 центр
  • Jagiellonian University — Krakow

Идентификаторы

NCT: NCT06793085 · 1072.6120.44.2024-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗