EUCTR2022-000161-40-AT
Active, Not Recruiting
Phase 1
Investigating cardiometabolic risk factors and changes in chronobiology patterns in patients with autonomous adrenal cortisol secretion
Medical University of Vienna, Division of Endocrinology0 sites50 target enrollmentJune 8, 2022
DrugsMetopirone
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medical University of Vienna, Division of Endocrinology
- Enrollment
- 50
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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