Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

NCT ID: NCT04833192

Last Updated: 2022-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Adrenal Incidentaloma Subclinical Hypercortisolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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experimental group

patients diagnosed with subclinical hypercortisolism as assessed by an endocrinologist.

experimental group

Intervention Type DIAGNOSTIC_TEST

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.

No interventions assigned to this group

Interventions

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experimental group

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Dalong Zhu

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dalong Zhu, MD,PhD

Role: CONTACT

13805150781

Facility Contacts

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Dalong Zhu, MD,PhD

Role: primary

86-25-83-105302

Ping Li, MD,PhD

Role: backup

86-25-83-105302

References

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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.

Reference Type DERIVED
PMID: 35137142 (View on PubMed)

Other Identifiers

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LP2021

Identifier Type: -

Identifier Source: org_study_id

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