Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-02 @ 12:07 AM
Study NCT ID:
NCT04833192
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2021-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
Study Overview
Official Title:
The Cross-sectional Study and Longitudinal Study of the Diagnostic Efficiency of Serum Dehydroepiandrosterone Sulfate in Subclinical Hypercortisolism
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: