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HypercortisolismCEMNCT05255900

Effects of Metyrapone in Patients With Hypercortisolism

An observational study of Hypercortisolism, run by Istituto Auxologico Italiano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hypercortisolism
What is being tested?
Metyrapone Capsules
Type of treatment
Pill or oral medicine
How many people
20 participants
Where
1 siteItaly
Study dates
28 Apr 2022to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with hypercortisolism referred to the outpatient clinic who were already on metirapone therapy.

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Auxologico Italiano

    Milan, 20149

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Metyrapone Capsules
Keywords
cortisol, metyrapone, hypercortisolism, mild hypercortisolism
Medical subject headings
Cushing Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metyrapone CapsulesDrug

    Exposure to 24 weeks of treatment with metyrapone

Study groups in NCT05255900
Study groupRoleWhat they receive
metyrapone treatmenthypercortisolemic patients taking metyrapone since less than a week (usually 250 mg/day, maximum dose 6000 mg/day)
Receives: Drug: Metyrapone Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with a mean systolic BP reduction of ≥5 mm Hg

    BP levels will be measured with arterial blood pressure monitoring (ABPM)

    Measured: Baseline, 24 weeks

Secondary outcomes (6)

  1. Changes in glycometabolic control

    1. the proportion of patients without type 2 diabetes achieving normalization of FG (<100 mg/dL) and/or the reduction of 2-hour glucose levels below 140 mg/dL after OGTT; ii) the proportion of patients with type 2 diabetes achieving HbA1c <7% among those with baseline HbA1c ≥7%;

    Measured: 12 and 24 weeks

  2. Normalization of cortisol circadian rhythm

    The cortisol circadian rhythm will be assessed by salivary cortisol levels determination (at 8 AM, 12 AM, 4 PM, 8 PM and 11 PM).

    Measured: baseline, 12 weeks, 24 weeks.

  3. Changes of thrombotic risk parameters

    The thrombotic risk profile will be evaluated by measuring C-Protein, S-Protein, coagulation factor VIII and anti-thrombin III levels

    Measured: Baseline, 12 and 24 weeks

  4. Changes of lipid profile

    The lipid profile modifications will be evaluated by measuring total cholesterol, low-density lipoprotein, high-density lipoprotein and triglycerides

    Measured: Baseline, 12 and 24 weeks

  5. Changes of bone turnover markers

    The bone turnover changes will be assessed by measuring calcium, phosphorous, osteocalcin (OC), carboxy-terminal cross-linked telopeptide of type I collagen (CTX) and 24-h urinary calcium/creatinine ratio

    Measured: Baseline, 12 and 24 weeks

  6. Amelioration of psychological symptoms

    Psychological symptoms wil be evaluated with Beck Depression Inventory-II (BDI-II), a 21-item self-administered inventory designed to measure the intensity of depressive symptoms (Beck, Steer, \& Brown, 1996). Scores ranging between 0 and 13 are indicative of minimal depression; scores that fall between 14 and 19 are considered to reflect a mild level of depression; scores of 20 to 28 are considered moderate; and a score ranging from 29 to 63 is labeled severe.

    Measured: Baseline, 12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start28 Apr 2022
  3. Primary completion30 Jun 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05255900
Sponsor's protocol ID
05J102
Acronym
CEM
Status last verified
Mar 2026
First submitted
14 Feb 2022
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zavatta G, Di Dalmazi G. Recent Advances on Subclinical Hypercortisolism. Endocrinol Metab Clin North Am. 2018 Jun;47(2):375-383. doi: 10.1016/j.ecl.2018.01.003. Epub 2018 Apr 9.

    PubMed 29754638

  • 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.

    PubMed 27212038

  • 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.

    PubMed 21367932

  • Morelli V, Arosio M, Chiodini I. Cardiovascular mortality in patients with subclinical Cushing. Ann Endocrinol (Paris). 2018 Jun;79(3):149-152. doi: 10.1016/j.ando.2018.03.005. Epub 2018 Mar 30.

    PubMed 29606280

  • Patrova J, Kjellman M, Wahrenberg H, Falhammar H. Increased mortality in patients with adrenal incidentalomas and autonomous cortisol secretion: a 13-year retrospective study from one center. Endocrine. 2017 Nov;58(2):267-275. doi: 10.1007/s12020-017-1400-8. Epub 2017 Sep 8.

    PubMed 28887710

  • Di Dalmazi G, Vicennati V, Garelli S, Casadio E, Rinaldi E, Giampalma E, Mosconi C, Golfieri R, Paccapelo A, Pagotto U, Pasquali R. Cardiovascular events and mortality in patients with adrenal incidentalomas that are either non-secreting or associated with intermediate phenotype or subclinical Cushing's syndrome: a 15-year retrospective study. Lancet Diabetes Endocrinol. 2014 May;2(5):396-405. doi: 10.1016/S2213-8587(13)70211-0. Epub 2014 Jan 29.

    PubMed 24795253

  • Debono M, Bradburn M, Bull M, Harrison B, Ross RJ, Newell-Price J. Cortisol as a marker for increased mortality in patients with incidental adrenocortical adenomas. J Clin Endocrinol Metab. 2014 Dec;99(12):4462-70. doi: 10.1210/jc.2014-3007.

    PubMed 25238207

  • Morelli V, Reimondo G, Giordano R, Della Casa S, Policola C, Palmieri S, Salcuni AS, Dolci A, Mendola M, Arosio M, Ambrosi B, Scillitani A, Ghigo E, Beck-Peccoz P, Terzolo M, Chiodini I. Long-term follow-up in adrenal incidentalomas: an Italian multicenter study. J Clin Endocrinol Metab. 2014 Mar;99(3):827-34. doi: 10.1210/jc.2013-3527. Epub 2014 Jan 1.

    PubMed 24423350

  • Park J, De Luca A, Dutton H, Malcolm JC, Doyle MA. Cardiovascular Outcomes in Autonomous Cortisol Secretion and Nonfunctioning Adrenal Adenoma: A Systematic Review. J Endocr Soc. 2019 Mar 25;3(5):996-1008. doi: 10.1210/js.2019-00090. eCollection 2019 May 1.

    PubMed 31065617

  • Chiodini I, Vainicher CE, Morelli V, Palmieri S, Cairoli E, Salcuni AS, Copetti M, Scillitani A. MECHANISMS IN ENDOCRINOLOGY: Endogenous subclinical hypercortisolism and bone: a clinical review. Eur J Endocrinol. 2016 Dec;175(6):R265-R282. doi: 10.1530/EJE-16-0289. Epub 2016 Jul 13.

    PubMed 27412441

  • Morelli V, Ghielmetti A, Caldiroli A, Grassi S, Siri FM, Caletti E, Mucci F, Aresta C, Passeri E, Pugliese F, Di Giorgio A, Corbetta S, Scillitani A, Arosio M, Buoli M, Chiodini I. Mental Health in Patients With Adrenal Incidentalomas: Is There a Relation With Different Degrees of Cortisol Secretion? J Clin Endocrinol Metab. 2021 Jan 1;106(1):e130-e139. doi: 10.1210/clinem/dgaa695.

    PubMed 33017843

  • Li D, Kaur RJ, Zhang CD, Ebbehoj A, Singh S, Atkinson EJ, Achenbach SJ, Rocca W, Khosla S, Bancos I. Risk of bone fractures after the diagnosis of adrenal adenomas: a population-based cohort study. Eur J Endocrinol. 2021 Apr;184(4):597-606. doi: 10.1530/EJE-20-1396.

    PubMed 33606665

  • Terzolo M, Pia A, Reimondo G. Subclinical Cushing's syndrome: definition and management. Clin Endocrinol (Oxf). 2012 Jan;76(1):12-8. doi: 10.1111/j.1365-2265.2011.04253.x.

    PubMed 21988204

  • Vassiliadi DA, Partsalaki E, Tsagarakis S. Approach to patients with bilateral adrenal incidentalomas. Curr Opin Endocrinol Diabetes Obes. 2020 Jun;27(3):125-131. doi: 10.1097/MED.0000000000000536.

    PubMed 32209820

  • Vassiliadi DA, Ntali G, Vicha E, Tsagarakis S. High prevalence of subclinical hypercortisolism in patients with bilateral adrenal incidentalomas: a challenge to management. Clin Endocrinol (Oxf). 2011 Apr;74(4):438-44. doi: 10.1111/j.1365-2265.2010.03963.x.

    PubMed 21175735

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercortisolism, run by Istituto Auxologico Italiano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with a mean systolic BP reduction of ≥5 mm Hg (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05255900, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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