Effects of Metyrapone in Patients With Hypercortisolism

NCT ID: NCT05255900

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-28

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Hypercortisolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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metyrapone treatment

hypercortisolemic patients taking metyrapone since less than a week (usually 250 mg/day, maximum dose 6000 mg/day)

Metyrapone Capsules

Intervention Type DRUG

Exposure to 24 weeks of treatment with metyrapone

Interventions

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Metyrapone Capsules

Exposure to 24 weeks of treatment with metyrapone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HRA Pharma

INDUSTRY

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chiodini Chiodini, Professor

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano IRCCS

Locations

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Istituto Auxologico Italiano

Milan, , Italy

Site Status

Countries

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Italy

References

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Other Identifiers

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05J102

Identifier Type: -

Identifier Source: org_study_id

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