Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.
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: Biological dosage.
- Кому может быть актуально
- Состояния в реестре: Obesity. 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
We postulate that childhood traumas are associated with deregulation of the glucocorticoid axis and the inflammatory system in obese women. The main objective of the study is to compare the salivary cortisol awaking response in obese women according to the presence of childhood trauma (assessed using the Childhood Trauma Questionnaire, CTQ).
Подробное описание
Obesity is an epidemic disease whose onset and development factors go beyond the simple energy balance. Current management strategies are often failing. It is therefore important to identify the underlying determinants of weight gain. The association of obesity in adulthood with trauma in childhood is now well established. However, the biological factors that account for this association are imperfectly known. The measurement of cortisol seems to be the most relevant biological marker of the link between obesity and life events. The majority of studies show that obesity is associated with increased exposure to glucocorticoids. However, some authors have recently reported that these measures are impacted by significant inter-individual variability which could be explained by differences in life events and especially in their perception. In addition, the autonomic nervous system with the secretion of catecholamines by the adrenal leads to the release of pro-inflammatory cytokines, resulting in a low grade inflammation.
The existence of childhood traumas and the association with other psychopathological disorders will be assessed using psychometric scales validated in French. The corticotropic axis will be evaluated by measuring cortisol in different matrices (saliva, urine, hair). The inflammatory state will be studied thanks to the determination of pro-inflammatory cytokines level in blood and immunophenotyping of myeloid-derived suppressor cells.
Вмешательства
- Биопрепарат Biological dosage
Metabolic, hormonal and psychometric evaluations will be carried out during inclusion inflammatory parameters, hormonal, capillary, saliva and urine assays will also be carried out at inclusion
Первичные конечные точки
- Measurement of salivary cortisol awakening response (CAR) [Срок оценки: Day 0]
Вторичные конечные точки (10)
- Comparison of the amount of urinary free cortisol [Срок оценки: Day 21]
- Comparison of the amount of urinary free cortisol metabolites [Срок оценки: Day 21]
- Comparison of the amount of salivary cortisone [Срок оценки: Day 21]
- Comparison of the amount of hair cortisol/cortisone [Срок оценки: Day 21]
- comparison of the proportions of current anxiety/depression [Срок оценки: Day 0]
- comparison of the proportions of current post-traumatic stress disorder (PTSD) [Срок оценки: Day 0]
- comparison of the proportion of current eating disorders [Срок оценки: Day 0]
- Dosage of several parameters of inflammation (CRP, IL-1beta, IFN-alpha2, IFN-gamma, TNF-alpha, CCL2 (MCP-1), IL-6, CXCL8 (IL-8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, l'IL-33, T lymphocytes and Myeloid-Derived Suppressor Cells immunophenotyping) [Срок оценки: Day 21]
- comparison of body composition [Срок оценки: Day -7]
- Comparison of the choice of treatment modality [Срок оценки: Day 21]
Критерии участия
Критерии включения
- ≥18 years female BMI≥30kg/m2
Критерии исключения
- History of bariatric surgery
- Any condition or pathology that may influence the corticotropic axis or that may modify the excretion or dosage of cortisol:
- pregnancy, breastfeeding
- hepatocellular insufficiency,
- severe heart failure,
- mild/moderate acute heart failure,
- any psychological disorder not stabilised for at least one year
- alcohol or drug dependence, not weaned for at least one year
- neoplasm under treatment
- Current infectious disease or a history of autoimmune disease (except autoimmune hypothyroidism), inflammatory disease and/or neurodegenerative disease
- Presence of an adrenal adenoma or any known or suspected clinical adrenal or corticotropic disorder
- Subjects with a positive diagnosis of hypercorticism or suspected hypercorticism will also be excluded: 8-hour plasma cortisol after Dexamethasone suppression test (DST) (1 mg dexamethasone taken orally at midnight the previous day) greater than 1.8 microg/100 ml (50 nmol/l)
- antidepressant and neuroleptic treatment, benzodiazepine treatment
- treatment(s) likely to modify the exploration of the corticotropic axis: systemic or local corticosteroid therapy or glucocorticoid infiltration for less than 6 months
- current use of anti-inflammatory drugs or antibiotics
- Shift worker
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
Франция · 1 центр
- LimogesUniversity Hospital — Limoges
Идентификаторы
NCT: NCT05237440 · 87RI21_0055 (OBEVIE)