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Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04833192
Enrollment
202
Registered
2021-04-06
Start date
2020-04-01
Completion date
2023-12-30
Last updated
2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Incidentaloma, Subclinical Hypercortisolism

Keywords

serum dehydroepiandrosterone sulfate, adrenocorticotropic hormone, surgical management, conservative management

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.

Interventions

DIAGNOSTIC_TESTexperimental group

DHEAS.24h-UFC,ACTH and cortisol are measured in the experimental group

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
dexamethasone suppression test2 dayDexamethasone 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
The gender and age of the participants1 dayage in years and sex (female or male) of patients
Participant's weight and height1 dayBMI(body mess index) in kg/m\^2= (weight in kg) /(height in m)\^2
the diurnal rhythm of ACTH2 dayplasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight
the the diurnal rhythm of cortisol2 dayserum cortisol in nmol/L at 8:00 am, 16:00 pm and 24:00 midnight measured on the same day as plasma ACTH
Patients' baseline DHEAS level1 dayserum DHEAS in ug/dL
CT imaging of adrenal tumor1 daydiameter in cm of adrenal adenoma

Secondary

MeasureTime frameDescription
the changes of DHEAS after conservative management12 months after the conservative management (for subclinical hypercortisolism with conservative management)DHEAS in ug/dL
the changes of ACTH after surgical management1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)ACTH in pmol/L
the changes of DHEAS after surgical management1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)DHEAS in ug/dL
the changes of ACTH after conservative management12 months after the conservative management (for subclinical hypercortisolism with conservative management)ACTH in pmol/L
the changes of cortisol after conservative management12 months after the conservative management (for subclinical hypercortisolism with conservative management)cortisol in nmol/L
the changes of cortisol after surgical management1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)cortisol in nmol/L

Countries

China

Contacts

Primary ContactDalong Zhu, MD,PhD
zhudldr@gmail.com13805150781

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026