This study will compare the efficacy and safety of the two 11β-hydroxylase inhibitors-metyrapone and osilodrostat-in patients with MACS. Primary 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. Secondary 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
metyrapone( 250 -750 mg) vs. osilodrostat (1-3 mg) vs. surgery vs watch and wait strategy in the management of patients with MACS
administration of 1-3 mg of osilodrostat at 19.00
Surgery performed in patients with MACS
Follow-up
Laikon General Hospital
Athens, Greece
RECRUITINGComparison of the efficacy of metyrapone and osilodrostat
Blood tests measuring baseline moring cortisol (μg/dl) levels pre and post-treatment
Time frame: Baseline ( at t=0), at t=3 months and at =6 months
Comparison of the efficacy of metyrapone and osilodristat
Measurement of the baseline morning ACTH (pg/ml) pre and post-treatment
Time frame: Baseline (at t= 0), at t= 3 months and t= 6 months
Comparison of the efficacy of metyrapone and osilodristat
Measurement of the baseline morning DHEAS levels (μg/dl) pre and post-treatment
Time frame: Baseline ( at t=0), at t=3 months and at t=6 months
Comparison of the efficacy of metyrapone and osilodristat
Measurement of urinary free cortisol (μg/24h) pre and post-treatment
Time frame: Baseline ( at t=0), at t=3 months and at =6 months
Comparison of metyrapone and osilodrostat efficacy
Measurement of salivary midnight cortisol (μg/dl) pre and post-treatment
Time frame: Baseline (at t=0), at t=3 months , at t =6 months
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alteartions of LDL levels (mg/dl) pre and post-treatment
Time frame: Baseline (t=0), at t= 3months, at t=6 months
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of fasting blood glucose levels (mg/dl) pre and post-treatment
Time frame: Baseline at t=0 , at 3 months and at 6 months
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alteration of insuline levels (μU/ml) pre and post-treatment
Time frame: Baseline (t=0), at t=3 months and at t=6 months
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of Hb1Ac levels (%) pre and post-treatment
Time frame: Baseline (t=0), at t=3 months and at t=6 months
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of HOMA-IR (glucose levels mmol/l x insuline levels mIU/L/22.5) pre and post -treatment
Time frame: Baseline (t=0) at t=3 months and t=6 months
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of cholesterol levels (mg/dl) pre and post-treatment
Time frame: Baseline (t=0), at t=3 months and at t=6 months
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of triglycerides levels (mg/dl) pre and post-treatment
Time frame: Baseline (t=0), at t=3 months and at t=6 months
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of HDL levels (mg/dl) pre and post-treatment
Time frame: Baseline (t=0), at t=3 months and at t=6 months
Comparison of metyrapone and osilodrostat in terms of alterations of metabolic parameters
Alterations of glucose levels post-OGTT pre and post-treatment
Time frame: Baseline at t=0, at t=3 months , at t=6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.