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Diagnostic treatment-trial for autonomous cortisol secretion- a tool to select patients for adrenalectomy (Metycor)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514143-28-00
Acronym
2024-514143-28-00
Enrollment
100
Registered
2024-11-11
Start date
2025-08-01
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild autonomous cortisol secretion

Brief summary

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, 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, 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

Detailed description

Weight reduction of more than 2 kg during the treatment period of 6 months is considered a significant weight reduction, 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., A 5% decrease in LDL- cholesterol is considered significant after a treatment periode of 6 months with Metycor., 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., BMI will be measured/calculated at baseilinge, 3 months and 6 monts. The effect on BMI will be calculated between baseline and 6 months.

Interventions

DRUGMetycor 250 mg myke kapsler

Sponsors

Helse Bergen HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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, 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, 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

Secondary

MeasureTime frame
Weight reduction of more than 2 kg during the treatment period of 6 months is considered a significant weight reduction, 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., A 5% decrease in LDL- cholesterol is considered significant after a treatment periode of 6 months with Metycor., 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., BMI will be measured/calculated at baseilinge, 3 months and 6 monts. The effect on BMI will be calculated between baseline and 6 months.

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026