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临床试验/NCT06309498
NCT06309498招募中不适用

Residual Adrenal Function in Addison's Disease

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
prevalence of RAF

研究概览

简要总结

The main aim of this study is to assess the role of 11-deoxycortisol as surrogate marker of Residual adrenal function.

11-deoxycortisol levels will be assessed in all recruited patients

详细描述

Addison's disease is an autoimmune disease characterized by inadequate secretion of cortisol and aldosteron by adrenal cortex as a consequence of progressive destruction of the adrenal gland. The absence of specific signs and symptoms could delay the diagnosis and treatment. Considering the importance of these two hormones, a not adequate treatment can result in Addisonian crisis and even be a cause of increased mortality.

Actually, diagnosis is based either on low basal cortisol levels or cortisol levels after Synacthen test (250 mcg) < 500 nmol/L.

Adrenal insufficiency (AI) is most of the time the inevitable end result of the autoimmune process, but some cases of partial recovery of adrenal function in a patient with autoimmune Addison's disease have been described.

Recent evidence shows that 5-30% of Addison's patients, also after many years of disease, maintain a residual endogenous corticosteroid production thanks to a partial adrenal cortex functionality, known as residual adrenal function (RAF).

Indeed, some studies show how the 3-15% of patients have detectable cortisol at Synacthen 250 mcg test, demonstrating that in one third of patients with long-standing disease, some RAF was still present.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Autoimmune Addison's disease
  • Informed consent

排除标准

  • Drugs affecting immune system or steroids other than hydrocortisone or cortisone acetate

结局指标

主要结局

prevalence of RAF

时间窗: baseline

residual adrenal function

次要结局

  • prevalence of adrenal crisis(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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