The Cross-sectional Study and Longitudinal Study of the Diagnostic Efficiency of Serum Dehydroepiandrosterone Sulfate in Subclinical Hypercortisolism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- the diurnal rhythm of ACTH
研究概览
简要总结
The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism
详细描述
In the past few years, with the widespread use of chest and abdominal imaging, the prevalence of adrenal incidentaloma (AIs) has been increasing and now approaches the 8.7% incidence reported in autopsy series. subclinical hypercortisolism (SH) is noted in up to 30% of patients with adrenal incidentalomas. Several groups have reported adverse clinical sequelae in individuals with SH, with recent studies highlighting an increase in cardiovascular morbidity and mortality compared to the general population. Accurate exclusion or confirmation of a diagnosis of SH is therefore a key step in the investigation and management of patients with AIs. Suppressed adrenocorticotropic hormone (ACTH) and low dehydroepiandrosterone sulfate (DHEAS) levels are frequently found in SH patients. Present study added new evidence for the limitations of ACTH and confirmed the usefulness of DHEAS for the detection of SH especially with unsuppressed ACTH in AI patients. On one hand, in the cross-sectional study, biometric measurements and sex hormones (including DHEAS, 24h-UFC, ACTH and cortisol) are analysed to explore the differences among SH patients, and nonfunctional adrenal adenoma patients. One the other hand, in the longitudinal study, changes in DHEAS, ACTH and cortisol in SH with surgical management and SH with conservative management both at baseline and different follow-up months after their different treatment management are collected to explore the changes of DHEAS and ACTH of SH patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with adrenal accidental tumor (diameter > 1cm) found by physical examination or imaging examination due to non-adrenal diseases
排除标准
- •concomitant use of drugs influencing glucocorticoid metabolism or secretion
- •major psychiatric illness or history of excess alcohol intake
- •overt clinical features of hypercortisolism
- •clinical and endocrine function evaluation (surgery patients at the same time reference to postoperative pathology) revealed primary aldosteronism, pheochromocytoma, adrenocortical carcinoma, adrenal metastasis of cancer, myelolipoma; oncocytoma, congenital adrenal cortex hyperplasia and ganglion cells neuroma/paraganglioma, schwannoma, adrenal hematoma and uncertain diagnosis)
- •non-adenoma lesions such as cysts and hemorrhage
- •The pregnancy
- •Patients with severe underlying diseases (such as liver and kidney failure, acute severe infection, etc.) that may affect the function of the hypothalamus-pituitary-adrenal axis (HPA axis)
结局指标
主要结局
the diurnal rhythm of ACTH
时间窗: 2 day
plasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight
The gender and age of the participants
时间窗: 1 day
age in years and sex (female or male) of patients
Participant's weight and height
时间窗: 1 day
BMI(body mess index) in kg/m\^2= (weight in kg) /(height in m)\^2
the the diurnal rhythm of cortisol
时间窗: 2 day
serum cortisol in nmol/L at 8:00 am, 16:00 pm and 24:00 midnight measured on the same day as plasma ACTH
CT imaging of adrenal tumor
时间窗: 1 day
diameter in cm of adrenal adenoma
Patients' baseline DHEAS level
时间窗: 1 day
serum DHEAS in ug/dL
dexamethasone suppression test
时间窗: 2 day
Dexamethasone 1mg (0.75mg/ tablet, 1.5 tablets) was taken orally at 24:00 midnight, and plasma ACTH in pmol/L and serum cortisol in cortisol levels were measured by blood sample at 8:00 the next day
次要结局
- the changes of cortisol after surgical management(1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment))
- the changes of ACTH after conservative management(12 months after the conservative management (for subclinical hypercortisolism with conservative management))
- the changes of cortisol after conservative management(12 months after the conservative management (for subclinical hypercortisolism with conservative management))
- the changes of DHEAS after surgical management(1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment))
- the changes of DHEAS after conservative management(12 months after the conservative management (for subclinical hypercortisolism with conservative management))
- the changes of ACTH after surgical management(1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment))
研究者
Dalong Zhu
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School