Investigating the effects of mildly increased cortisol secretion on cardio metabolic risk factors

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000161-40-AT

Enrollment

Registered

2022-06-08

Start date

2022-07-18

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomous cortisol secretion in patients with adrenal adenoma

Interventions

Trade Name: Metopirone Product Name: Metopirone Pharmaceutical Form: Capsule INN or Proposed INN: METYRAPONE CAS Number: 54-36-4 Concentration unit: mg milligram(s) Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For patients with autonomous cortisol secretion: i) morning cortisol > 1,8 ug/dl following 1 mg dexamethasone suppression test, 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

Exclusion criteria: • HbA1c > 8 % and/or treatment with insulin therapy • 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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Cardiometabolic phenotyping of patients suffering from autonomous cortisol secretion;Secondary Objective: Identifying a disease specific chronobiology profile in patients with altered hypothalamus-pituitary-adrenal (HPA) axis signaling Investigating the impact of a treatment by metyrapone on cardiometabolic risk factors in patients with autonomous adrenal cortisol secretion;Primary end point(s): Hepatic lipid content (HCL) assessed by 1H magnetic resonance spectroscopy;Timepoint(s) of evaluation of this end point: Before and after 12 weeks of treatment with metyrapone	—

Measure

Time frame

Main Objective: Cardiometabolic phenotyping of patients suffering from autonomous cortisol secretion;Secondary Objective: Identifying a disease specific chronobiology profile in patients with altered hypothalamus-pituitary-adrenal (HPA) axis signaling Investigating the impact of a treatment by metyrapone on cardiometabolic risk factors in patients with autonomous adrenal cortisol secretion;Primary end point(s): Hepatic lipid content (HCL) assessed by 1H magnetic resonance spectroscopy;Timepoint(s) of evaluation of this end point: Before and after 12 weeks of treatment with metyrapone

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Secondary

Measure	Time frame
Secondary end point(s): 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 parameters of systemic inflammation parameters of the Renin-Angiotensin-Aldosterone system activation hypercoagulability assessment by thrombin generation assays standardized clinical chronotype evaluation by Munich ChronoType Questionnaire and psychological testing body temperature measurements during the day by an actimetry watch analyses of peroxiredoxin oxidation cycles from red blood cells circadian clock transcript changes from peripheral blood mononuclear cells combined untargeted/targeted LC-MS/MS based approaches concentrations of testosterone and adrenal androgen precursors gender specific differences;Timepoint(s) of evaluation of this end point: Before and after 12 weeks of treatment with metyrapone	—

Measure

Time frame

Secondary end point(s): 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 parameters of systemic inflammation parameters of the Renin-Angiotensin-Aldosterone system activation hypercoagulability assessment by thrombin generation assays standardized clinical chronotype evaluation by Munich ChronoType Questionnaire and psychological testing body temperature measurements during the day by an actimetry watch analyses of peroxiredoxin oxidation cycles from red blood cells circadian clock transcript changes from peripheral blood mononuclear cells combined untargeted/targeted LC-MS/MS based approaches concentrations of testosterone and adrenal androgen precursors gender specific differences;Timepoint(s) of evaluation of this end point: Before and after 12 weeks of treatment with metyrapone

—

Countries

Austria

Contacts

Public ContactSecretary, Leitstelle 6J

Medical University of Vienna, Division of Endocrinology

peter.wolf@meduniwien.ac.at004314040043100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026