Effects of Metyrapone in Patients With Hypercortisolism (NCT05255900) | Clinical Trial Compass
CompletedNot Applicable
Effects of Metyrapone in Patients With Hypercortisolism
Italy20 participantsStarted 2022-04-28
Plain-language summary
The aims of the present study are to evaluate in patients with mild hypercortisolism the effect of metyrapone treatment on glycometabolic control, blood pressure, thrombotic risk parameters, lipid profile, bone turnover markers, mental health and cortisol circadian rhythm.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with mild Cushing's Syndrome not candidate for surgery
* Current therapy with metyrapone since less than 1 week
* Cortisol levels at 08:00 after 1 mg-overnight dexamethasone suppression test (1mgDST) \>1.8 μg/dL
* Confirmed with 2 mg two days dexamethasone suppression test (2mgx2dDST)
* Presence of at least one out of the following conditions: type 2 diabetes mellitus, impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT), arterial hypertension, bone mineral density (BMD) Z-score \< -2.0 and/or fragility fracture at any skeletal site
* Stable anti-hypertensive therapies and blood pressure (BP) levels in the month before enrolment
* Stable anti-diabetic therapies and glycometabolic control during the month before enrolment
* Stable body weight during the month before enrolment
Exclusion Criteria:
* Signs and/or symptoms of overt hypercortisolism (striae rubrae, moon facies, easy bruising, buffalo hump, hypertrichosis)
* Malignant hypertension and/or BP \<200/120 mmHg
* Severe hyperglycemia (i.e. FG \>350 mg/dL)
* Urinary free cortisol (UFC) higher than 1.5 fold the upper normal range
* Presence of pheochromocytoma or primary hyperaldosteronism
* Possible adrenal metastases or radiological features suggestive for adrenal malignancy (i.e. not homogeneous pattern, necrosis, calcifications, irregular margins, local invasion and high density at computed tomography)
* Congenital adrenal hyperplasia
* Intake of drugs influencing cort…
What they're measuring
1
Proportion of patients with a mean systolic BP reduction of ≥5 mm Hg