Effects of Metyrapone in Patients With Hypercortisolism (CEM)

Istituto Auxologico Italiano

Status

Active, not recruiting

Conditions

Hypercortisolism

Treatments

Drug: Metyrapone Capsules

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05255900

05J102

Details and patient eligibility

About

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.

Full description

This open prospective observational study will include patients with mild hypercortisolism of both adrenal and pituitary origin not candidate for surgery. Patients taking metyrapone since less than a week will be followed up for 24 weeks. During this period of time, patients will be re-evaluated as far as blood pressure control, glycometabolic control, thrombotic risk parameters, lipid profile, bone turnover markers and cortisol circadian rhythm is concerned.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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 cortisol metabolism and/or secretion
Women in child-bearing age
Patients with body mass index (BMI) >35 kg/m2