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

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

Study Overview

• Status: Recruiting
• Conditions: Adrenal Incidentaloma; Subclinical Hypercortisolism
• Intervention / Treatment: Diagnostic test: experimental group

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 Type: Observational
• Enrollment (Anticipated): 202

Contacts and Locations

• Study Contact: Name: Dalong Zhu, MD,PhD; Phone Number: 13805150781; Email: zhudldr@gmail.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • at Divison of Endocrinology,the Affiliated Drum Tower Hospital of Nanjing University
      • Contact: Ping Li, MD,PhD; Phone Number: 86-25-83-105302; Email: lp78321@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

subclinical hypercortisolism and adrenal nonfunctional adenoma patients

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
experimental group; patients diagnosed with subclinical hypercortisolism as assessed by an endocrinologist.	Diagnostic test: experimental group; DHEAS.24h-UFC,ACTH and cortisol are measured in the experimental group
control grpup; patients diagnosed with nonfunctional adrenal adenoma as assessed by an endocrinologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The gender and age of the participants	age in years and sex (female or male) of patients	1 day
Participant's weight and height	BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2	1 day
the diurnal rhythm of ACTH	plasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight	2 day
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
Patients' baseline DHEAS level	serum DHEAS in ug/dL	1 day
CT imaging of adrenal tumor	diameter in cm of adrenal adenoma	1 day
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
the changes of DHEAS after conservative management	DHEAS in ug/dL	12 months after the conservative management (for subclinical hypercortisolism with conservative management)
the changes of ACTH after conservative management	ACTH in pmol/L	12 months after the conservative management (for subclinical hypercortisolism with conservative management)
the changes of cortisol after conservative management	cortisol in nmol/L	12 months after the conservative management (for subclinical hypercortisolism with conservative management)

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: April 3, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: adrenocorticotropic hormone; conservative management; surgical management; serum dehydroepiandrosterone sulfate
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Cushing Syndrome; Adrenocortical Hyperfunction; Adrenocortical Adenoma
• Other Study ID Numbers: LP2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO