Investigating the effects of mildly increased cortisol secretion on cardio metabolic risk factors
- Conditions
- Autonomous cortisol secretion in patients with adrenal adenomaTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2022-000161-40-AT
- Lead Sponsor
- Medical University of Vienna, Division of Endocrinology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method