Effects of Metyrapone in Patients With Hypercortisolism
NCT ID: NCT05255900
Last Updated: 2025-09-08
Study Results
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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ACTIVE_NOT_RECRUITING
20 participants
OBSERVATIONAL
2022-04-28
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
Exposure to 24 weeks of treatment with metyrapone
Interventions
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Metyrapone Capsules
Exposure to 24 weeks of treatment with metyrapone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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HRA Pharma
INDUSTRY
Istituto Auxologico Italiano
OTHER
Responsible Party
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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
Countries
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References
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Chiodini I, Morelli V. Subclinical Hypercortisolism: How to Deal with It? Front Horm Res. 2016;46:28-38. doi: 10.1159/000443862. Epub 2016 May 17.
Chiodini I. Clinical review: Diagnosis and treatment of subclinical hypercortisolism. J Clin Endocrinol Metab. 2011 May;96(5):1223-36. doi: 10.1210/jc.2010-2722. Epub 2011 Mar 2.
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Pasternak JD, Seib CD, Seiser N, Tyrell JB, Liu C, Cisco RM, Gosnell JE, Shen WT, Suh I, Duh QY. Differences Between Bilateral Adrenal Incidentalomas and Unilateral Lesions. JAMA Surg. 2015 Oct;150(10):974-8. doi: 10.1001/jamasurg.2015.1683.
Morelli V, Palmieri S, Salcuni AS, Eller-Vainicher C, Cairoli E, Zhukouskaya V, Scillitani A, Beck-Peccoz P, Chiodini I. Bilateral and unilateral adrenal incidentalomas: biochemical and clinical characteristics. Eur J Endocrinol. 2013 Jan 17;168(2):235-41. doi: 10.1530/EJE-12-0777. Print 2013 Feb.
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Chiodini I, Albani A, Ambrogio AG, Campo M, De Martino MC, Marcelli G, Morelli V, Zampetti B, Colao A, Pivonello R; ABC Group. Six controversial issues on subclinical Cushing's syndrome. Endocrine. 2017 May;56(2):262-266. doi: 10.1007/s12020-016-1017-3. Epub 2016 Jul 12.
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Bancos I, Alahdab F, Crowley RK, Chortis V, Delivanis DA, Erickson D, Natt N, Terzolo M, Arlt W, Young WF Jr, Murad MH. THERAPY OF ENDOCRINE DISEASE: Improvement of cardiovascular risk factors after adrenalectomy in patients with adrenal tumors and subclinical Cushing's syndrome: a systematic review and meta-analysis. Eur J Endocrinol. 2016 Dec;175(6):R283-R295. doi: 10.1530/EJE-16-0465. Epub 2016 Jul 22.
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Other Identifiers
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05J102
Identifier Type: -
Identifier Source: org_study_id
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