Status:
ACTIVE_NOT_RECRUITING
Effects of Metyrapone in Patients With Hypercortisolism
Lead Sponsor:
Istituto Auxologico Italiano
Collaborating Sponsors:
HRA Pharma
Conditions:
Hypercortisolism
Eligibility:
All Genders
18-85 years
Brief 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 pro...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05255900
Start Date
April 28 2022
End Date
December 1 2025
Last Update
September 8 2025
Active Locations (1)
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1
Istituto Auxologico Italiano
Milan, Italy, 20149