Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome

Eligibility criteria

Qualifiers

Unilateral or bilateral adrenal nodules with benign features associated with thickening of the adrenal arms >5 mm on abdominal CT scan

Cortisol levels after dexamethasone 1 mg test >50 nmol/L associated with baseline ACTH <10 pg/mL

Cortisol levels after dexamethasone 1 mg test >50 nmol/L associated with increased nocturnal (11 pm) salivary cortisol

Cortisol levels after dexamethasone 1 mg test >138 nmol/L

Disqualifiers

Body mass index ≥40 kg/m2

Pregnant or lactating women; diagnosis of pregnancy will be made by serum β-HCG assay

Women of childbearing age using contraceptive measures other than barrier contraception. Barrier contraceptive measures are: o Male or female condom with or without spermicide o Cervical cup, diaphragm or sponges with spermicide o Combination of male condom and cervical cup, diaphragm or sponges with spermicide (dual barrier methods)

Treatment with steroids in the last year before enrollment

Trial design

Treatments tested in this trial

  • Metarapone
  • Standardized antihypertensive therapy

Treatment groups

50 Participants
are divided into 2 treatment groups