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| Name | Class |
|---|---|
| Copenhagen University Hospital at Herlev | OTHER |
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The goal of this observational study is to evaluate the diagnostic accuracy of salivary cortisol compared with serum cortisol after a 1 mg overnight dexamethasone suppression test in participants (N = 100) with adrenal incidentalomas and healthy control participants (N = 100). The main question it aims to answer is:
Are salivary cortisol and serum cortisol equal diagnostic tools for endogenous hypercortisolism?
The inclusion of healthy controls will serve as a reference population to define the central 95 % reference interval for the serum and salivary cortisol levels.
Participants will undergo routine medical examination of adrenal incidentalomas including 1 mg dexamethasone-suppression-test, 24 h urine sample, and measurement of plasma-adrenocorticotropin (ACTH). In addition to the routine biochemical tests, saliva samples will be collected the morning and evening before intake of dexamethasone as well as the following morning together with serum cortisol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with adrenal incidentalomas |
| ||
| Healthy control group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 mg overnight dexamethasone suppression test | Diagnostic Test | Included participants will undergo routine medical examination including 1 mg dexamethasone-suppression-test, 24 h urine sample, and measurement of plasma-adrenocorticotropin (ACTH). In addition to the routine biochemical tests, saliva samples will be collected the morning and evening before intake of dexamethasone as well as the following morning together with serum cortisol. |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary cortisol and cortisone in patients and controls following an overnight dexamethasone suppression test | Cross-sectional evaluation of serum and salivary cortisol and cortisone after an overnight 1 mg dexamethasone suppression test in patients with adrenal incidentalomas and healthy controls. | Baseline (Day 0, 08:00-09:00 hour) and post-dexamethasone (Day 1, 08:00-09:00 hour) |
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Inclusion Criteria (patients):
Inclusion Criteria (controls):
Exclusion Criteria (patients):
Exclusion Criteria (controls):
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The patient group were patients newly diagnosed with an adrenal incidentaloma and referred to either the Department of Nephrology and Endocrinology, Copenhagen University Hospital, Rigshospi-talet, Denmark or Department of Medicine, Copenhagen University Hospital Herlev Gentofte, Herlev, Denmark.
The controls were recruited through social media, online participant recruitment platform , the hospital website, and physical posters in public spaces around Copenhagen, Denmark.
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| ID | Term |
|---|---|
| C538238 | Adrenal incidentaloma |
| D003480 | Cushing Syndrome |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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Plasma, serum, urine, saliva
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