[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613563":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":29,"centralContacts":39,"locations":46,"responsibleParty":58,"collaborators":29,"id":62,"slug":29,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":29,"enrollmentInfo":70,"targetDuration":29,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":49,"whyStopped":29,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Laikο General Hospital, Athens","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients with MACS","Patients with MACS (Adults \\> 18 years old with 1mg ODST F levels \\>1.8μg\u002Fdl and normal or slightly abnormal UFC OR midnight salivary cortisol levels AND no symptoms or signs of overt hypercortisolism.)",[12,13,14,15],"Drug: Metyrapone 250 mg Oral Tablets","Drug: Osilodrostat 1 MG","Procedure: adrenalectomy","Other: Watch and wait",[17,25,30,35],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Metyrapone 250 mg Oral Tablets","metyrapone( 250 -750 mg) vs. osilodrostat (1-3 mg) vs. surgery vs watch and wait strategy in the management of patients with MACS",[9],[23,24],"osilodrostat","surgery",{"type":18,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Osilodrostat 1 MG","administration of 1-3 mg of osilodrostat at 19.00",[9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"PROCEDURE","adrenalectomy","Surgery performed in patients with MACS",[9],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"Watch and wait","Follow-up",[9],[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Anna Angelousi, MD, PhD, Msc","CONTACT","00306978167876","0030","a.angelousi@gmail.com",[47],{"facility":48,"status":49,"city":50,"state":29,"zip":29,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":29},"Laikon General Hospital","RECRUITING","Athens","Greece",{"type":53,"coordinates":54},"Point",[55,56],23.72784,37.98376,{"lat":56,"lon":55},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Anna Angelousi","associate professor","100613563",false,"NCT07268222","Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)","MOMACS","Inclusion Criteria:\n\n* Adults \\> 18 years old with MACS and unilateral or bilateral adrenal adenomas or hyperplasia (based on imaging)\n* 1 mg overnight dexamethasone suppression test (ODST): Cortisol levels at 8.00 am\\>1.8 μg\u002Fdl AND i) ACTH\\\u003C 15 pg\u002Fml OR ii) abnormal midnight salivary cortisol OR iii) Urinary free cortisol levels (UFC) \u002F24h ≥ of the UNL\n\nExclusion Criteria:\n\n* Abnormal liver enzymes\n* eGFR \\\u003C 40 ml\u002Fmin\u002F1.73 m3\n* Pseudocushing syndrome\n* Patients with any malignancy (active or past history), including ACC\n* ACTH-dependent Cushing syndrome (Cushing disease or ectopic Cushing syndrome)","ALL","18 Years",{"count":71,"type":72},150,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","This study will compare the efficacy and safety of the two 11β-hydroxylase inhibitors-metyrapone and osilodrostat-in patients with MACS.\n\nPrimary outcome To compare the efficacy (biochemical and clinical) of the two 11β-hydroxylase inhibitors (CYP11B1), metyrapone and osilodrostat, in patients with MACS not treated surgically (mainly bilateral adenomas or adrenal hyperplasias), as well as their side effects at time 0-, 3- and 6-months post-treatment.\n\nSecondary outcome To evaluate alterations in clinical parameters (Blood Pressure, Body Mass Index-BMI), metabolic parameters (fasting blood glucose, insulin, Hb1Ac, HOMA, OGTT and lipids levels) at time 0-, 3- and 6-month after the initiation of the treatment and their effect on Bone Mineral Density (BMD) 1 year post-diagnosis",[78],"Mild Autonomous Cortisol Secretion (MACS)",[80,81,82,83,23],"cortisol","Cushing","MACS","METYRAPONE","2025-12-03",{"date":86,"type":87},"2025-12-05","ACTUAL",{"date":89,"type":87},"2025-12-01",{"date":91,"type":72},"2027-11-25",{"name":5,"class":6},1]