Functional Proteins in Polycystic Ovary Syndrome
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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 kisspeptin concentration, Measurement of ghrelin concentration, Measurement of zonulin 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Assessment of the Concentrations of Functional Proteins as Potential Early Markers of Insulin Resistance in Women With Polycystic Ovary Syndrome
Обзор
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.
Подробное описание
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.
Вмешательства
- Диагностический тест Measurement of kisspeptin concentration
Measurement of kisspeptin concentration in fasting venous blood serum - Диагностический тест Measurement of ghrelin concentration
Measurement of ghrelin concentration in fasting venous blood serum - Диагностический тест Measurement of zonulin concentration
Measurement of zonulin concentration in fasting venous blood serum
Первичные конечные точки
- Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups [Срок оценки: up to 6 months]
- Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groups [Срок оценки: up to 6 months]
- Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups [Срок оценки: up to 6 moths]
Критерии участия
Критерии включения
- women aged 18-45 years
Критерии исключения
- 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: NCT06793098 · 1072.6120.44.2024-3