Diagnostic treatment-trial for autonomous cortisol secretion- a tool to select patients for adrenalectomy (Metycor)
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- 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
概览
简要总结
Assess improvement in hypertension, glucose metabolism, and cortisol levels in patients with ACS measured before and after a 6 months treatment trial with Metycor.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age.
- •Patients with ACS and one or more metabolic-, bone- and / or psychiatric complications.
- •The patient is eligible for surgical treatment with adrenalectomy
- •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.
排除标准
- •Patients with fulminant Cushing syndrome, who should be given priority for prompt surgery
- •Patients treated with Metycor at present, or before
- •Patinents treated with other cortisol lowering drugs
- •Patients hypersensitive/allergic to some of the substances in Metycor
- •The patient is not able to collaborate on the follow-up in the study
- •Women who are breastfeeding
- •Pregnant women
- •Patients with pituitary Cushing disease
- •Patients with low dexamethasone bioavailability as a reason for their positive Dexamethasone suppression test.
- •Patients using oral estrogens
结局指标
主要结局
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
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
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
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
次要结局
- 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.
研究者
Grethe Åstrøm Ueland
Scientific
Helse Bergen HF