Clinical trial NCT04833192: Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism
Official title: The Cross-sectional Study and Longitudinal Study of the Diagnostic Efficiency of Serum Dehydroepiandrosterone Sulfate in Subclinical Hypercortisolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adrenal Incidentaloma
Subclinical Hypercortisolism
Keywords: serum dehydroepiandrosterone sulfate
adrenocorticotropic hormone
surgical management
conservative management
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subclinical hypercortisolism and adrenal nonfunctional adenoma patients

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The gender and age of the participants
timeFrame: 1 day
measure: Participant's weight and height
timeFrame: 1 day
measure: the diurnal rhythm of ACTH
timeFrame: 2 day
measure: the the diurnal rhythm of cortisol
timeFrame: 2 day
measure: Patients' baseline DHEAS level
timeFrame: 1 day
measure: CT imaging of adrenal tumor
timeFrame: 1 day
measure: dexamethasone suppression test
timeFrame: 2 day
Secondary outcomes:
measure: the changes of DHEAS after surgical management
timeFrame: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
measure: the changes of ACTH after surgical management
timeFrame: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
measure: the changes of cortisol after surgical management
timeFrame: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
measure: the changes of DHEAS after conservative management
timeFrame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
measure: the changes of ACTH after conservative management
timeFrame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
measure: the changes of cortisol after conservative management
timeFrame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: at Divison of Endocrinology,the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
References:
citation: Liu MS, Lou Y, Chen H, Wang YJ, Zhang ZW, Li P, Zhu DL. Performance of DHEAS as a Screening Test for Autonomous Cortisol Secretion in Adrenal Incidentalomas: A Prospective Study. J Clin Endocrinol Metab. 2022 Apr 19;107(5):e1789-e1796. doi: 10.1210/clinem/dgac072.