Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism

Detailed Description
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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.

Official Title
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The Cross-sectional Study and Longitudinal Study of the Diagnostic Efficiency of Serum Dehydroepiandrosterone Sulfate in Subclinical Hypercortisolism

Conditions
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Adrenal Incidentaloma, Subclinical Hypercortisolism

Intervention / Treatment
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* Diagnostic Test: experimental group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with adrenal accidental tumor (diameter > 1cm) found by physical examination or imaging examination due to non-adrenal diseases Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| experimental group<br>patients diagnosed with subclinical hypercortisolism as assessed by an endocrinologist. | Diagnostic Test: experimental group<br>* DHEAS.24h-UFC,ACTH and cortisol are measured in the experimental group<br>|
| control grpup<br>patients diagnosed with nonfunctional adrenal adenoma as assessed by an endocrinologist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The gender and age of the participants | age in years and sex (female or male) of patients | 1 day | 
| Participant's weight and height | BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2 | 1 day | 
| the diurnal rhythm of ACTH | plasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight | 2 day | 
| the the diurnal rhythm of cortisol | serum cortisol in nmol/L at 8:00 am, 16:00 pm and 24:00 midnight measured on the same day as plasma ACTH | 2 day | 
| Patients' baseline DHEAS level | serum DHEAS in ug/dL | 1 day | 
| CT imaging of adrenal tumor | diameter in cm of adrenal adenoma | 1 day | 
| dexamethasone suppression test | 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 | 2 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of DHEAS after surgical management | DHEAS in ug/dL | 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment) | 
| the changes of ACTH after surgical management | ACTH in pmol/L | 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment) | 
| the changes of cortisol after surgical management | cortisol in nmol/L | 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment) | 
| the changes of DHEAS after conservative management | DHEAS in ug/dL | 12 months after the conservative management (for subclinical hypercortisolism with conservative management) | 
| the changes of ACTH after conservative management | ACTH in pmol/L | 12 months after the conservative management (for subclinical hypercortisolism with conservative management) | 
| the changes of cortisol after conservative management | cortisol in nmol/L | 12 months after the conservative management (for subclinical hypercortisolism with conservative management) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serum dehydroepiandrosterone sulfate, adrenocorticotropic hormone, surgical management, conservative management