Adrenal Incidentaloma Clinical Trial
Official title:
The Cross-sectional Study and Longitudinal Study of the Diagnostic Efficiency of Serum Dehydroepiandrosterone Sulfate in Subclinical Hypercortisolism
NCT number | NCT04833192 |
Other study ID # | LP2021 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2020 |
Est. completion date | December 30, 2023 |
The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism
Status | Recruiting |
Enrollment | 202 |
Est. completion date | December 30, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
China | at Divison of Endocrinology,the Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The gender and age of the participants | age in years and sex (female or male) of patients | 1 day | |
Primary | Participant's weight and height | BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2 | 1 day | |
Primary | the diurnal rhythm of ACTH | plasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight | 2 day | |
Primary | 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 | |
Primary | Patients' baseline DHEAS level | serum DHEAS in ug/dL | 1 day | |
Primary | CT imaging of adrenal tumor | diameter in cm of adrenal adenoma | 1 day | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | the changes of DHEAS after conservative management | DHEAS in ug/dL | 12 months after the conservative management (for subclinical hypercortisolism with conservative management) | |
Secondary | the changes of ACTH after conservative management | ACTH in pmol/L | 12 months after the conservative management (for subclinical hypercortisolism with conservative management) | |
Secondary | the changes of cortisol after conservative management | cortisol in nmol/L | 12 months after the conservative management (for subclinical hypercortisolism with conservative management) |
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