Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism

April 14, 2022 updated by: Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • at Divison of Endocrinology,the Affiliated Drum Tower Hospital of Nanjing University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The gender and age of the participants
Time Frame: 1 day
age in years and sex (female or male) of patients
1 day
Participant's weight and height
Time Frame: 1 day
BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2
1 day
the diurnal rhythm of ACTH
Time Frame: 2 day
plasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight
2 day
the the diurnal rhythm of cortisol
Time Frame: 2 day
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
Time Frame: 1 day
serum DHEAS in ug/dL
1 day
CT imaging of adrenal tumor
Time Frame: 1 day
diameter in cm of adrenal adenoma
1 day
dexamethasone suppression test
Time Frame: 2 day
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the changes of DHEAS after surgical management
Time Frame: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
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
Time Frame: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
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
Time Frame: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
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
Time Frame: 12 months after the conservative management (for subclinical hypercortisolism with 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
Time Frame: 12 months after the conservative management (for subclinical hypercortisolism with 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
Time Frame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
cortisol in nmol/L
12 months after the conservative management (for subclinical hypercortisolism with conservative management)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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