metyrapone for Mild autonomous cortisol secretion

Inclusion criteria

• {"criterion_text":"- Must be at least 18 years of age."}
• {"criterion_text":"- Patients with ACS and one or more metabolic-, bone- and / or psychiatric complications."}
• {"criterion_text":"- The patient is eligible for surgical treatment with adrenalectomy"}
• {"criterion_text":"- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations."}

Exclusion criteria

• {"criterion_text":"- Patients with fulminant Cushing syndrome, who should be given priority for prompt surgery"}
• {"criterion_text":"- Patients treated with Metycor at present, or before"}
• {"criterion_text":"- Patinents treated with other cortisol lowering drugs"}
• {"criterion_text":"- Patients hypersensitive/allergic to some of the substances in Metycor"}
• {"criterion_text":"- The patient is not able to collaborate on the follow-up in the study"}
• {"criterion_text":"- Women who are breastfeeding"}
• {"criterion_text":"- Pregnant women"}
• {"criterion_text":"- Patients with pituitary Cushing disease"}
• {"criterion_text":"- Patients with low dexamethasone bioavailability as a reason for their positive Dexamethasone suppression test."}
• {"criterion_text":"- Patients using oral estrogens"}
• {"criterion_text":"- Patients with adrenal insufficiency"}
• {"criterion_text":"- Patients with adrenocortical carsinomas"}
• {"criterion_text":"- Patients with co-secretion of aldosterone"}
• {"criterion_text":"- Patients with present or previous hearth disease"}
• {"criterion_text":"- Patients with electrolyte disturbances"}

Primary endpoints

• {"endpoint_text":"- Lowering of s-Cortisol levels by half and/or below 300 nmol/l in basal morning test based on assessments before and after a trial treatment period of 6 months","definition_or_measurement_approach":"Measured as basal morning serum cortisol in a basal morning test; endpoint defined as a reduction by half and/or below 300 nmol/l comparing assessments before and after 6 months of treatment."}
• {"endpoint_text":"- Reduction in Blood pressure with a 10 % reduction in systolic and /or diastolic blood pressure via standard blood pressure measurement and/ or a 5% nocturnal dip measured via 24 h blood pressure measurement based on assessments before and after a trial treatment period of 6 months","definition_or_measurement_approach":"Measured by standard blood pressure measurements and/or 24 h blood pressure monitoring; endpoint defined as 10% reduction in systolic and/or diastolic BP or a 5% nocturnal dip comparing baseline and 6 months."}
• {"endpoint_text":"- Significant improvement in glycemic control defined as 5% (5 mmol/mol) reduction in HbA1C, or 10% increase in TIR based on assessments before and after a trial treatment period of 6 months","definition_or_measurement_approach":"Measured by HbA1c (endpoint = 5% / 5 mmol/mol reduction) or Time in Range (TIR) (endpoint = 10% increase) comparing baseline and 6 months."}

Secondary endpoints

• {"endpoint_text":"- Weight reduction of more than 2 kg during the treatment period of 6 months is considered a significant weight reduction","definition_or_measurement_approach":"Weight measured at baseline and after 6 months; reduction >2 kg considered significant."}
• {"endpoint_text":"- There will be a categorically assessment whether there is a change in bone markers (PINP, CTX, osteoklasien) from degradation to build-up of bone, before compared to after treatment for 6 months with Metycor.","definition_or_measurement_approach":"Blood bone markers (PINP, CTX, osteoclast markers) measured at baseline and after 6 months; categorical assessment of change from degradation to build-up."}
• {"endpoint_text":"- A 5% decrease in LDL- cholesterol is considered significant after a treatment periode of 6 months with Metycor.","definition_or_measurement_approach":"LDL-cholesterol measured at baseline and after 6 months; a 5% decrease considered significant."}
• {"endpoint_text":"- Change in score of general quality of life measured as SF36, and disease-specific questionaire Cushing QoL will be assessed individually for each form, and baseline will be compared with 6 months.","definition_or_measurement_approach":"QoL assessed using SF-36 and Cushing QoL questionnaires at baseline and after 6 months; change in individual scores compared."}
• {"endpoint_text":"- BMI will be measured/calculated at baseilinge, 3 months and 6 monts. The effect on BMI will be calculated between baseline and 6 months.","definition_or_measurement_approach":"BMI measured at baseline, 3 months and 6 months; primary comparison between baseline and 6 months."}

Norway

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

11-11-2024

Processing Time Days

12

Number Of Sites

4

Number Of Participants

100

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"","full_name":"Novo Nordisk foundation","duties_or_roles":"Source of monetary support / funding","organisation_type":""}