Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

Adrenal Incidentaloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833192
• Other study ID #: LP2021
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Dalong Zhu, MD,PhD
• Phone: 13805150781
• Email: zhudldr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: December 30, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adrenal Incidentaloma
• Adrenocortical Adenoma
• Adrenocortical Hyperfunction
• Cushing Syndrome
• Subclinical Hypercortisolism

Intervention

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

Locations

Country	Name	City	State
China	at Divison of Endocrinology,the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The gender and age of the participants	age in years and sex (female or male) of patients	1 day
Primary	Participant's weight and height	BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2	1 day
Primary	the diurnal rhythm of ACTH	plasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight	2 day
Primary	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
Primary	Patients' baseline DHEAS level	serum DHEAS in ug/dL	1 day
Primary	CT imaging of adrenal tumor	diameter in cm of adrenal adenoma	1 day
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	the changes of DHEAS after conservative management	DHEAS in ug/dL	12 months after the conservative management (for subclinical hypercortisolism with conservative management)
Secondary	the changes of ACTH after conservative management	ACTH in pmol/L	12 months after the conservative management (for subclinical hypercortisolism with conservative management)
Secondary	the changes of cortisol after conservative management	cortisol in nmol/L	12 months after the conservative management (for subclinical hypercortisolism with conservative management)