An observational study in Adrenal Incidentaloma and Subclinical Hypercortisolism, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-15.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational
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The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism
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.
27 studies on the registry are indexed under Adrenal incidentaloma; 12 are open to participants now.
This study's planned enrollment of 202 is below the median of 300 across 18 observational studies indexed under Adrenal incidentaloma.
Browse Adrenal incidentaloma studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 250 studies on the registry; 147 are open to participants now.
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subclinical hypercortisolism and adrenal nonfunctional adenoma patients
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients diagnosed with subclinical hypercortisolism as assessed by an endocrinologist.
Diagnostic Test: experimental group
patients diagnosed with nonfunctional adrenal adenoma as assessed by an endocrinologist.
DHEAS.24h-UFC,ACTH and cortisol are measured in the experimental group
The gender and age of the participants
age in years and sex (female or male) of patients
Time frame: 1 day
Participant's weight and height
BMI(body mess index) in kg/m\^2= (weight in kg) /(height in m)\^2
Time frame: 1 day
the diurnal rhythm of ACTH
plasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight
Time frame: 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
Time frame: 2 day
Patients' baseline DHEAS level
serum DHEAS in ug/dL
Time frame: 1 day
CT imaging of adrenal tumor
diameter in cm of adrenal adenoma
Time frame: 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
Time frame: 2 day
the changes of DHEAS after surgical management
DHEAS in ug/dL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
the changes of ACTH after conservative management
ACTH in pmol/L
Time frame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
the changes of cortisol after conservative management
cortisol in nmol/L
Time frame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
Plan to share: No
Started Apr 2020 (actual). Primary completion is estimated for Apr 2023, 36 months after the start.
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School →