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Effects of Metyrapone in Patients With Hypercortisolism | Clinical Trials | Clareo Health

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Effects of Metyrapone in Patients With Hypercortisolism

Metabolic, Pressor and Neuropsychological Effects of Metyrapone Treatment in Patients With Hypercortisolism

NCT05255900•Istituto Auxologico Italiano

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.

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 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.

Eligibility

Age

18 - 85 years

Sex

ALL

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

Locations (1)

Istituto Auxologico Italiano

Milan, Italy

Key Dates

Start Date

April 28, 2022

Primary Completion Date

June 30, 2025

Completion Date

December 1, 2025

Last Updated

September 8, 2025

Enrollment

ESTIMATED participants

Conditions

Hypercortisolism

Interventions

Metyrapone Capsules

DRUG

Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism

NCT06246357

HyperaldosteronismHypercortisolism+1 more

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RECRUITINGNA

Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

NCT05368090

Primary AldosteronismAldosterone-Producing Adenoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Metyrapone in Patients With Hypercortisolism

Inclusion Criteria

Exclusion Criteria

Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism

Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension (MOMENTUM)

Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome

Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

Nailfold Capillaroscopy Evaluation in Cushing Syndrome Patients