Evaluating the effects of metyrapone in patients with mild hypercortisolism
Metabolic, Pressor and Neuropsychological Effects of Metyrapone Treatment in Patients With Hypercortisolism
This study is testing how well metyrapone works for people with mild hypercortisolism who can't have surgery, by looking at its effects on their overall health over 24 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT05255900 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of metyrapone treatment on various health parameters in patients diagnosed with mild hypercortisolism who are not candidates for surgery. Participants will be monitored over a 24-week period to evaluate changes in glycometabolic control, blood pressure, thrombotic risk factors, lipid profiles, bone turnover markers, mental health, and cortisol circadian rhythm. The study will include patients who have recently started metyrapone therapy and will involve regular follow-ups to gather comprehensive data on their health status.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with mild Cushing's Syndrome who are not eligible for surgical intervention and have recently begun treatment with metyrapone.
Not a fit: Patients exhibiting signs of overt hypercortisolism or those with malignant hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve management strategies for patients with mild hypercortisolism, potentially enhancing their overall health outcomes.
How similar studies have performed: While there have been studies on metyrapone, this specific approach focusing on mild hypercortisolism is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milano
- Istituto Auxologico Italiano — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Chiodini Chiodini, Professor — Istituto Auxologico Italiano IRCCS
- Study coordinator: Chiodini Chiodini, Professor
- Email: i.chiodini@auxologico.it
- Phone: 02619112506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.