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Идёт набор NCT06793072

Adipokines in Polycystic Ovary Syndrome

— Наблюдательное PCOS Reproductive Age

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: Leptin concentration in blood serum, Resistin concentration in blood serum, Omentin-1 concentration in blood serum.
Кому может быть актуально
Состояния в реестре: PCOS, Reproductive Age. 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 Adipokine Concentrations and Their Association With the Metabolic Profile of Women With PCOS

Обзор

The aim of the study is to compare the concentrations of leptin, resistin, and omentin-1 in women across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

Подробное описание

Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy among reproductive-age women, characterized primarily by insulin resistance (IR), which has a prevalence of 35% to 80%. Metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The hyperinsulinemic-euglycemic clamp study is regarded as the gold standard for assessing insulin sensitivity; however, its clinical application is limited. Alternative assessments, such as the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin or glucose tolerance tests, provide limited clinical utility. Therefore, there is a pressing need for the identification of more precise and universal markers of insulin resistance. There is a need to elucidate the precise role of adipokines in the etiology of PCOS and their association with insulin resistance, which is responsible for the development of adverse health-related complications.

The aim of the study is to measure and compare the concentrations of selected adipokines: leptin, resistin, omentin-1 across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

The tests will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer.

The concentrations of the investigated substances will be measured and compared within the three research groups.

Statistical analysis will be conducted using SPSS Statistics software.

Вмешательства

  • Диагностический тест Leptin concentration in blood serum
    Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms
  • Диагностический тест Resistin concentration in blood serum
    Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms
  • Диагностический тест Omentin-1 concentration in blood serum
    Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms

Первичные конечные точки

  • Comparison of resistin concentration in three study groups [Срок оценки: up to 6 months]
  • Comparison of leptin concentration three study groups [Срок оценки: up to 6 months]
  • Comparison of omentin-1 concentration in three study groups [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

  • Age 18-45

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(Edited)Restore original

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 Univeristy — Krakow

Идентификаторы

NCT: NCT06793072 · 1072.6120.44.2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗