Adrenalectomy Versus Follow-up in Patients With Mild Hypercortisolism: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Region Skane
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Improvement of blood pressure as assessed by 24 hours blood pressure measurement
研究概览
简要总结
Incidental findings of adrenal tumours,"incidentalomas", occur in 1-5 % in the general population and 10-25 % of these patients will exhibit biochemical mild hypercortisolism. Although the patients do not have clinical signs of classical Cushing's syndrome, they have an increased risk for hypertension, dyslipidemia, diabetes mellitus, osteoporosis and obesity.
The hypothesis of the study is, that surgery of the adrenal adenoma responsible for the increased secretion of cortisol, will in part cure or ameliorate the metabolic syndrome.
详细描述
Adrenal incidentalomas, adrenal tumours detected without symptoms and signs of hormonal hypersecretion or malignancy, are common. Depending on modality (MRI, CT. Ultrasonography) adrenal tumours occur in approximately 1-5% of the population. In about 10% of patients, the tumours are bilateral. At autopsy studies adrenal tumours occur in 1% of patients under the age of 30, but in approximately 7% of patients older than 70 years. Investigation of the adrenal tumours focus on to exclude malignancy (which is uncommon), and an increased secretion of hormones (adrenaline, aldosterone, cortisol), so-called functional tumours. However, most often adrenal incidentalomas are non-functional. The most common functional disorder is increased secretion of cortisol, and then usually without clinical stigmata, known as subclinical Cushing's syndrome (or mild hypercortisolism). Clinical stigmata, Cushing's syndrome, is empirically associated with elevated levels of urinary cortisol.
Subclinical Cushing's syndrome occurs in 10-25% of patients with adrenal incidentalomas. The incidence has been estimated at 0.8 / 1,000 inhabitants, making it a common disease.
Diagnosis is based to detect an autonomous release of cortisol from the adrenal gland (a disorder of the so-called hypothalamic-pituitary-adrenal axis).
Fundamental to the diagnosis is that the secretion of cortisol is not inhibited <50 nmol / L at 8.00, after an overnight test with 1 mg of oral dexamethasone.
In addition, at least one of the following criteria for disturbance of the hypothalamic-pituitary-adrenal axis is suggested to be present:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adrenal tumour with biochemical mild hypercortisolism defined as pathological dexamethasone suppression test (cortisol > 50 nmol/L at 8.00 am after 1 mg dexamethasone at 10 pm, plus one of the following criteria
- •Low or suppressed adrenocorticotropic hormone (ACTH)
- •Low or suppressed dehydroepiandrosterone (DHEA)
- •No or pathological circadian rhythm of cortisol
排除标准
- •Increased levels of 24 hours urinary excretion of cortisol
- •Pregnancy or lactation
- •Inability to understand information or to comply with scheduled follow-up
- •Mild hypercortisolism with bilateral adrenal tumours, without a gradient (lateralization on venous sampling)
结局指标
主要结局
Improvement of blood pressure as assessed by 24 hours blood pressure measurement
时间窗: At two years after intervention
Blood pressure assessed by 24 hours measurement is considered to be improved if at least one of the following outcomes has occurred, and is sustained, during 2 years of follow-up: 1. Normalization of hypertension without medical treatment 2. Unchanged or decreased blood pressure in patients with hypertension if the number or dose of the patient's antihypertensive drug (s) has been reduced 3. Unchanged normal blood pressure in patients who were normotensive at the time of randomization.
次要结局
- Decreased body mass index (BMI) to < 30(At two years post intervention)
- Cardiac function(At two years post intervention)
- Cognitive function(At two years after intervention)
- Atherosclerosis(At two years after intervention)
- Normalization of diabetes mellitus(At two years after intervention)
- Blood lipids(At two years post intervention)
- Bone density(At two years post intervention)
- Quality of Life assessed by SF 36(At two years after intervention)
- Adrenal cortical insufficiency(At two years after intervention)