Morbidity and Mortality in Patients With Adrenal Incidentalomas With and Without Autonomous Cortisol Secretion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 4,596
- 试验地点
- 1
- 主要终点
- Number of patients deceased, both totally and divided into three specified diagnose groups (cardiovascular disease, infections and cancer).
研究概览
简要总结
Benign enlargements of the adrenal glands (adrenal adenomas) are frequent in adults. In the general population these adenomas are rare in subjects below 40 years of age but at the age of 60 and 80 years the prevalence is 6 and 8-10 % respectively. Since these adenomas do not causes obvious symptoms they are almost exclusively found incidentally in patients examined radiologically for other reasons than suspected adrenal disease. These enlargements are thus termed adrenal incidentalomas (AI). AI may secrete cortisol and more than 25 percent of patients with an AI have increased cortisol levels called autonomous cortisol secretion (ACS). Such increased secretion of cortisol may cause metabolic complications such as hypertension, high cholesterol, diabetes and cardiovascular disease. Studies have shown that ACS may cause increased mortality. These studies are however small and have not adequately taking other conditions into account which most likely influences the result.
The investigators hypothesis is that ACS is linked to increased mortality as the previous studies have shown. The aim is to perform a larger study on patients with adrenal incidentalomas, both with and without ACS, and compare the mortality rates with a control group matched for age and sex. This study may more precisely describe the cardiovascular risk for ACS and define the risk at different levels of ACS.
详细描述
Patients with adrenal adenomas may have autonomous cortisol secretion (ACS) that has been linked to hypertension, diabetes, dyslipidemia and cardiovascular disease. Patients with ACS also have been found to have increased mortality. In two studies the excess mortality was caused by cardiovascular disease and in one study by cancer.
ACS is diagnosed by increased cortisol (≥50 nmol/l) following 1-mg dexamethasone suppression (DST) often in combination with another confirmatory test such as low ACTH, increased urinary cortisol, increased midnight salivary cortisol or a dexamethasone suppression test with a higher dexamethasone dose. Cortisol secretion from an AI has been considered exclusively autonomous but the investigators have recently shown that a large group of patients with normal results on DST have low ACTH indicating that another factor than ACS may suppress the HPA-axis. The hypothesis is that these patients have an increased sensitivity to ACTH, which results in lower ACTH levels. It has however not been studied whether the increased sensitivity to ACTH is linked to increased cardiovascular morbidity and mortality.
Patient data is collected from the patient cards and radiology images. Patients are included according to the eligibility criteria. The patients will be separated in the following groups:
- No ACS, inhalation steroids or adrenalectomy.
- ACS/possible-ACS but not treatment with inhalation steroids or adrenalectomy
- Treatment inhalation steroids but not operated.
- Unilateral AI and treated with adrenalectomy but no inhalation steroids. The group is separated in patients without ACS and patients with possible ACS/ACS.
Three age and gender matched subjects from the general population for every patient will serve as a controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with adrenal incidentalomas examined at Skane University Hospital and Helsingborg Hospital during the period from January 1, 2005 to September 15, 2015.
排除标准
- •Size of incidentaloma below 1 cm
- •Malignant disease with metastases,
- •Incidentaloma not an adenoma but for example malignancy, myelolipoma and bleedings
- •Pheochromocytomas
- •Primary aldosteronism
- •Continuous treatment with systemic glucocorticoid under the last 3 months.
- •Cushing Syndrome
- •Medication affecting dexamethasone metabolism.
- •Treatment with systemic estrogen
结局指标
主要结局
Number of patients deceased, both totally and divided into three specified diagnose groups (cardiovascular disease, infections and cancer).
时间窗: From date of enrollment until December 31, 2018.
The cause of death is defined by the ICD-10 code reported by The National Board of Health and Welfare.
次要结局
- A composite of cardiovascular death, nonfatal myocardial infarction (excluding silent myocardial infarction), nonfatal stroke, hospitalization for heart failure and revascularization (CABG and PCI). The endpoints will also be calculated separately.(From date of enrollment until December 31, 2017.)
研究者
Henrik Olsen
Principal Investigator Henrik Olsen, MD, PhD.
Region Skane