Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

  • End date
    Dec 30, 2023
  • participants needed
  • sponsor
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Updated on 2 May 2022
Accepts healthy volunteers


The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism


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.

Condition Adrenal Incidentaloma, Subclinical Hypercortisolism
Treatment Experimental group
Clinical Study IdentifierNCT04833192
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Last Modified on2 May 2022


Yes No Not Sure

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)
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