2024-512100-19-00
Recruiting
Phase 4
Investigating cardiometabolic risk factors and changes in chronobiology patterns in patients with autonomous adrenal cortisol secretion
Medical University Of Vienna1 site in 1 country50 target enrollmentStarted: October 14, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Medical University Of Vienna
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Hepatic lipid content (HCL) assessed by 1H magnetic resonance spectroscopy
Overview
Brief Summary
Cardiometabolic phenotyping of patients suffering from autonomous cortisol secretion and identifying a disease specific chronobiology profile in patients with altered hypothalamus-pituitary-adrenal (HPA) axis signaling
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Group autonomous cortisol secretion: Inclusion criteria for the ACS group: • Age > 18 years • History of an adrenal adenoma • morning cortisol > 1.8 ug/dl following 1 mg dexamethasone suppression test • No classical clinical features associated with the presence of Cushing’s syndrome, Control group: • Age > 18 years • History of an adrenal adenoma • morning cortisol of ≤ 1.8 ug/dl following 1 mg dexamethasone suppression testing
Exclusion Criteria
- •HbA1c > 8 % and/or treatment with insulin therapy 14 Proposal_AdrenalClock_V4 18.03.2023 • uncontrolled hypertension (RR > 170/110 mmHg; treatment with no more than 4 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
Hepatic lipid content (HCL) assessed by 1H magnetic resonance spectroscopy
Hepatic lipid content (HCL) assessed by 1H magnetic resonance spectroscopy
Secondary Outcomes
- insulin secretion and sensitivity based on validated indices (HOMA_IR, CLIX) • subcutaneous and visceral fat mass, body composition • Systolic and diastolic heart function, epicardial and pericardial fat mass • ectopic lipid deposition in the skeletal muscle and the myocardium • standardized blood pressure measurements (blood pressure for 24h hours and Schellong tests) • parameters of systemic inflammation (CRP, Il-6, PAI-1, TNF-alpha, homocysteine, leucocytes, monocytes)
Investigators
Department of Endocrinology and Metabolism
Scientific
Medical University Of Vienna
Study Sites (1)
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