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临床试验/EUCTR2022-000161-40-AT
EUCTR2022-000161-40-AT进行中(未招募)1 期

Investigating cardiometabolic risk factors and changes in chronobiology patterns in patients with autonomous adrenal cortisol secretion

Medical University of Vienna, Division of Endocrinology0 个研究点目标入组 50 人开始时间: 2022年6月8日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • For patients with autonomous cortisol secretion:
  • i) morning cortisol > 5 ug/dl following 1 mg dexamethasone suppression test or ii) cortisol 1,8-5 ug/dl following 1 mg dexamethasone suppression test with a low morning ACTH concentration (ACTH < 10 pg/ml), without classical clinical features associated with the presence of Cushing’s syndrome.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • HbA1c > 7 % and/or treatment with other anti-diabetics than metformin and/or DPP-IV inhibitors
  • uncontrolled hypertension (RR > 170/110 mmHg; treatment with no more than 3 antihypertensive drugs)
  • previous treatment with glucocorticoids within the last 3 months
  • concomitant treatment with drugs affecting HPA signaling or CYP3A4 metabolism
  • adrenal tumor with radiological criteria suspicious for malignancy
  • chronic kidney disease (eGFR < 45 ml/min)
  • liver disease (ASAT / ALAT > 3 x ULN)
  • pregnancy or breast feeding
  • general MR contraindications (claustrophobia, metal devices or other magnetic material in the body which will be hazardous for MR investigation

研究者

发起方
Medical University of Vienna, Division of Endocrinology

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