Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
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: Adrenalectomy.
- Кому может быть актуально
- Состояния в реестре: Adrenal Incidentaloma, Hypercortisolism, Adrenal Tumor. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- 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
Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
Обзор
The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can improve metabolic parameters and cardiovascular risks and features.
Подробное описание
Adrenal incidentalomas are clinically silent masses discovered inadvertently during diagnostic imaging procedures performed for unrelated reasons. Depending on the criteria applied, up to 50% of patients with adrenal incidentalomas may have biochemical evidence of cortisol excess. Possible autonomous cortisol secretion (pACS), as defined in the 2016 European Society of Endocrinology Guidelines, is characterized by a partial, incomplete suppression of the hypothalamic-pituitary-adrenal (HPA) axis without the typical signs of overt cortisol hypersecretion.
Investigators will perform a prospective longitudinal study in patients with adrenal incidentalomas associated with possible autonomous cortisol secretion, aiming to assess the effect of surgical and conservative management on cardiovascular and metabolic features.
Data will be detected at baseline, at 1 and at 5 years follow-up to quantitatively identify the different cardiovascular and metabolic alterations in: (1) patients with non-functioning adrenal adenoma; (2) patients with possible autonomous cortisol secretion receiving conservative management; (3) patients with possible autonomous cortisol secretion receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines; (4) patients without adrenal masses.
Вмешательства
- Процедура Adrenalectomy
Adrenalectomy according to 2016 ESE guidelines
Первичные конечные точки
- Echocardiographic Change of Left Ventricular Hypertrophy [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
Вторичные конечные точки (12)
- Change of arterial stiffness and blood pressure using brachial oscillometric blood pressure waves for a noninvasive estimation. [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Change of blood pressure using ambulatory blood pressure monitoring blood pressure waves for a noninvasive estimation. [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Change in blood Coagulation Tests [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Change in Dual X-Ray Absorptiometry T-score [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Radiological evaluation of adrenal mass [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Evaluation of sleep disturbances using questionnaire (PSQI) [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Infectious diseases frequency and severity with modified German Diseases Questionnaire [Срок оценки: Baseline (T0), after 1 year (t1) and 5 years (t2)]
- Quality of life: SF-36-Item Health Survey questionnaire [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Psychometric Evaluation: Beck Depression Inventory questionnaire [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Evaluation of sexual dysfunction using FSFI questionnaire in woman [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Evaluation of sexual dysfunction using IIEF questionnaire in man [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
- Change in insulin resistance calculated with HOMA index [Срок оценки: at Baseline (T0) and after 1 year (t1) and 5 years (t2)]
Критерии участия
Критерии включения
- Incidentally detected adrenal mass
Критерии исключения
- Patients with overt Cushing's syndrome, pheochromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage
- Patients taking medications influencing glucocorticoid production or metabolism
- Patients with psychiatric diseases or alcohol abuse
- Pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Италия · 1 центр
- Department of Experimental Medicine — Rome
Публикации
- De Alcubierre D, Ferrari D, Tomaselli A, Moscucci F, Bonaventura I, Francia A, Vozza E, Lospinuso I, Ettorre E, Hasenmajer V, Minnetti M, Sbardella E, Tenuta M, Morelli S, Paganini AM, Isidori AM, Pofi R. Long-term cardiac effects of adrenalectomy versus surveillance in mild cortisol excess: 5-year results from the prospective ITACA study. Eur J Endocrinol. 2026 Feb 4;194(2):170-184. doi: 10.1093/ PMID 41572809
Идентификаторы
NCT: NCT04127552 · ITACA