Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Comparison of the efficacy of metyrapone and osilodrostat
研究概览
简要总结
This study will compare the efficacy and safety of the two 11β-hydroxylase inhibitors-metyrapone and osilodrostat-in patients with MACS.
Primary outcome To compare the efficacy (biochemical and clinical) of the two 11β-hydroxylase inhibitors (CYP11B1), metyrapone and osilodrostat, in patients with MACS not treated surgically (mainly bilateral adenomas or adrenal hyperplasias), as well as their side effects at time 0-, 3- and 6-months post-treatment.
Secondary outcome To evaluate alterations in clinical parameters (Blood Pressure, Body Mass Index-BMI), metabolic parameters (fasting blood glucose, insulin, Hb1Ac, HOMA, OGTT and lipids levels) at time 0-, 3- and 6-month after the initiation of the treatment and their effect on Bone Mineral Density (BMD) 1 year post-diagnosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 18 years old with MACS and unilateral or bilateral adrenal adenomas or hyperplasia (based on imaging)
- •1 mg overnight dexamethasone suppression test (ODST): Cortisol levels at 8.00 am>1.8 μg/dl AND i) ACTH< 15 pg/ml OR ii) abnormal midnight salivary cortisol OR iii) Urinary free cortisol levels (UFC) /24h ≥ of the UNL
排除标准
- •Abnormal liver enzymes
- •eGFR < 40 ml/min/1.73 m3
- •Pseudocushing syndrome
- •Patients with any malignancy (active or past history), including ACC
- •ACTH-dependent Cushing syndrome (Cushing disease or ectopic Cushing syndrome)
研究组 & 干预措施
Patients with MACS
Patients with MACS (Adults > 18 years old with 1mg ODST F levels >1.8μg/dl and normal or slightly abnormal UFC OR midnight salivary cortisol levels AND no symptoms or signs of overt hypercortisolism.)
干预措施: Metyrapone 250 mg Oral Tablets (Drug)
Patients with MACS
Patients with MACS (Adults > 18 years old with 1mg ODST F levels >1.8μg/dl and normal or slightly abnormal UFC OR midnight salivary cortisol levels AND no symptoms or signs of overt hypercortisolism.)
干预措施: Osilodrostat 1 MG (Drug)
Patients with MACS
Patients with MACS (Adults > 18 years old with 1mg ODST F levels >1.8μg/dl and normal or slightly abnormal UFC OR midnight salivary cortisol levels AND no symptoms or signs of overt hypercortisolism.)
干预措施: adrenalectomy (Procedure)
Patients with MACS
Patients with MACS (Adults > 18 years old with 1mg ODST F levels >1.8μg/dl and normal or slightly abnormal UFC OR midnight salivary cortisol levels AND no symptoms or signs of overt hypercortisolism.)
干预措施: Watch and wait (Other)
结局指标
主要结局
Comparison of the efficacy of metyrapone and osilodrostat
时间窗: Baseline ( at t=0), at t=3 months and at =6 months
Blood tests measuring baseline moring cortisol (μg/dl) levels pre and post-treatment
Comparison of the efficacy of metyrapone and osilodristat
时间窗: Baseline ( at t=0), at t=3 months and at =6 months
Measurement of urinary free cortisol (μg/24h) pre and post-treatment
Comparison of metyrapone and osilodrostat efficacy
时间窗: Baseline (at t=0), at t=3 months , at t =6 months
Measurement of salivary midnight cortisol (μg/dl) pre and post-treatment
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
时间窗: Baseline (t=0), at t= 3months, at t=6 months
Alteartions of LDL levels (mg/dl) pre and post-treatment
次要结局
- Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters(Baseline at t=0, at t=3 months , at t=6 months)
研究者
Anna Angelousi
associate professor
Laikο General Hospital, Athens