Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

NCT04833192 | Unknown

• 1 other identifier: LP2021
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adrenal Incidentaloma; Subclinical Hypercortisolism

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• the changes of DHEAS after surgical management

  1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)

• the changes of ACTH after surgical management

  1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)

• the changes of cortisol after surgical management

  1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)

• the changes of DHEAS after conservative management

  12 months after the conservative management (for subclinical hypercortisolism with conservative management)

• the changes of ACTH after conservative management

  12 months after the conservative management (for subclinical hypercortisolism with conservative management)

Study Arms (2)

experimental group

patients diagnosed with subclinical hypercortisolism as assessed by an endocrinologist.

Diagnostic Test: experimental group

control grpup

patients diagnosed with nonfunctional adrenal adenoma as assessed by an endocrinologist.

Interventions

experimental group DIAGNOSTIC_TEST

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

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

subclinical hypercortisolism and adrenal nonfunctional adenoma patients

You may qualify if:

• patients with adrenal accidental tumor (diameter \> 1cm) found by physical examination or imaging examination due to non-adrenal diseases

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

at Divison of Endocrinology,the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35137142 DERIVED

MeSH Terms

Conditions

Adrenal incidentaloma

Central Study Contacts

Dalong Zhu, MD,PhD

CONTACT

13805150781; zhudldr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: April 6, 2021
• Study Start: April 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: December 30, 2023
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)