Oxytocin in Postmenopausal Women
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: Repeated assessments.
- Кому может быть актуально
- Состояния в реестре: Postmenopausal, Premenopausal. Базовые параметры: от 18 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
- Швейцария
- 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
Circulating Oxytocin and Its Clinical Correlates in Postmenopausal Women Compared With Premenopausal Controls - The OxyMENO Study
Обзор
The aim of the present study is to assess whether cumulative endogenous neurophysin I secretion over one month differs between premenopausal and postmenopausal women. Using repeated measurements of neurophysin-I (NP-I, equimolar surrogate marker of oxytocin) across defined physiological time points, this study investigates oxytocin system regulation under cyclic and non-cyclic hormonal conditions. The primary hypothesis is that cumulative NP-I release, expressed as the area under the curve (AUC) is lower in the postmenopausal group compared to the premenopausal group.
Подробное описание
Oxytocin (OXT) plays a key role in pair-bonding behavior, social cognition, stress regulation and emotional processing, while peripherally it regulates parturition, lactation, and smooth muscle function. Beyond reproductive physiology, OXT has been implicated in numerous other metabolic functions. It has been suggested to exert cardioprotective effects, including attenuation of cardiac apoptosis and fibrosis, negative chronotropic and inotropic actions \[7\], and anti-inflammatory effects. Furthermore, it has been associated with the regulation of glucose homeostasis and pain perception.
In women, elevated OXT levels have been suggested to enhance cognitive control over food cravings. While a clinical study including 55 women examined postprandial OXT levels across different menstrual phases, data on fasting OXT levels across an entire cycle in premenopausal women, as well as comparisons with postmenopausal women, remain scarce. In general, most research on the relation between OXT and food intake has been done outside the context of the menstrual cycle or in clinical populations (e.g. patients with bulimia nervosa).
The synthesis, release and expression of OXT are modulated by sex steroids, particularly estrogen. Across the menstrual cycle, circulating OXT levels exhibit dynamic changes in women of reproductive age. Menopause, however, is characterized by complete cessation of ovarian function leading to sustained estrogen deficiency and loss of cyclical hormonal regulation. A longitudinal assessment of circulating OXT across a physiological menstrual cycle, compared with repeated measurements in postmenopausal women, may provide a more robust characterization of OXT secretion patterns. Quantifying NP-I release over time using the area under the curve (AUC) may overcome limitations of single time-point measurements and improve understanding of menopause-related alterations in OXT physiology. The aim of the present study is to assess whether cumulative endogenous NP-I secretion (equimolar OXT surrogate marker) over one month differs between premenopausal and postmenopausal women
Вмешательства
- Другое Repeated assessments
This study is an observational investigation involving repeated venous blood sampling and non-invasive clinical assessments ov four study visits.
Первичные конечные точки
- Area under the curve of Neurophysin-1 (NP-I) [Срок оценки: 1 month]
Вторичные конечные точки (12)
- Cycle-phase-specific OXT/NP-I concentrations [Срок оценки: 1 month]
- Gonadal Hormone concentrations [Срок оценки: 1 month]
- Psychological and affective measures - anxiety [Срок оценки: 1 month]
- Psychological and affective measures - depression [Срок оценки: 1 month]
- Psychological and affective measure - sleep quality [Срок оценки: 1 month]
- Climacteric symptoms [Срок оценки: 1 month]
- Emotion recognition performance [Срок оценки: 1 month]
- Empathy [Срок оценки: 1 month]
- Socio-affective processing [Срок оценки: 1 month]
- Stress reactivity - subjective stress rating [Срок оценки: 1 month]
- Stress reactivity - autonomic measures [Срок оценки: 1 month]
- Stress reactivity - endocrine stress markers [Срок оценки: 1 month]
Критерии участия
Критерии включения
- Female sex at birth
- Age ≥18 years
Premenopausal group:
- Premenopausal women aged 18-35 years with regular menstrual cycles (21-35 days) for ≥3 months prior to study entry
Postmenopausal group:
- Postmenopausal women ≥2 years of postmenopause (i.e. 3 years since last menstrual period (LMP), with menopause defined as ≥ 12 months of amenorrhea)
Критерии исключения
- Pregnancy or breastfeeding
- Use of hormonal contraception or hormone replacement therapy within the last 3 months
- Known endocrine disorders affecting the hypothalamic-pituitary-gonadal axis
- Use of medications
- Severe depression (BDI score > 28 points), any other severe psychiatric illness or acute medical disease
- Inability to comply with study procedures
- Participation in a trial with investigational drugs within the last 30 days
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 1 центр
- University Hospital Basel — Basel
Идентификаторы
NCT: NCT07742124 · 2026-01136 - kt26ChristCrain4