Clinical trial · Observational
Morbidity and Mortality in Autonomous Cortisol Secretion
Morbidity and Mortality in Patients With Adrenal Incidentalomas With and Without Autonomous Cortisol Secretion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Benign enlargements of the adrenal glands (adrenal adenomas) are frequent in adults. In the general population these adenomas are rare in subjects below 40 years of age but at the age of 60 and 80 years the prevalence is 6 and 8-10 % respectively. Since these adenomas do not causes obvious symptoms they are almost exclusively found incidentally in patients examined radiologically for other reasons than suspected adrenal disease. These enlargements are thus termed adrenal incidentalomas (AI). AI may secrete cortisol and more than 25 percent of patients with an AI have increased cortisol levels called autonomous cortisol secretion (ACS). Such increased secretion of cortisol may cause metabolic complications such as hypertension, high cholesterol, diabetes and cardiovascular disease. Studies have shown that ACS may cause increased mortality. These studies are however small and have not adequately taking other conditions into account which most likely influences the result. The investigators hypothesis is that ACS is linked to increased mortality as the previous studies have shown. The aim is to perform a larger study on patients with adrenal incidentalomas, both with and without ACS, and compare the mortality rates with a control group matched for age and sex. This study may more precisely describe the cardiovascular risk for ACS and define the risk at different levels of ACS.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Incidentaloma | — | UNRESOLVED | — |
| Cortisol Overproduction | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (5)
- label
- AI ACS/possible ACS
- description
- Patients with adrenal incidentalomas and cortisol following overnight 1-mg dexamethasone suppression equal to or above 50 nmol/l. The patients should not have clinical signs of Cushing Syndrome, such as catabolic skin and muscle changes.
- label
- AI non-ACS
- description
- Patients with adrenal incidentalomas and cortisol following overnight 1-mg dexamethasone suppression below 50 nmol/l.
- label
- Treatment with Inhalation Steroids
- description
- Patients treated with inhalation steroids with and without ACS/possible ACS but not operated with adrenalectomy.
- label
- Adrenalectomy
- description
- Patients with unilateral AI operated with adrenalectomy
- label
- Controls
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients with adrenal incidentalomas examined at Skane University Hospital and Helsingborg Hospital during the period from January 1, 2005 to September 15, 2015. Exclusion Criteria: 1. Size of incidentaloma below 1 cm 2. Malignant disease with metastases, 3. Incidentaloma not an adenoma but for example malignancy, myelolipoma and bleedings 4. Pheochromocytomas 5. Primary aldosteronism 6. Continuous treatment with systemic glucocorticoid under the last 3 months. 7. Cushing Syndrome 8. Medication affecting dexamethasone metabolism. 9. Treatment with systemic estrogen
References
Publications (7)
- BACKGROUNDFassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467. PMID 27390021
- BACKGROUNDDebono M, Bradburn M, Bull M, Harrison B, Ross RJ, Newell-Price J. Cortisol as a marker for increased mortality in patients with incidental adrenocortical adenomas. J Clin Endocrinol Metab. 2014 Dec;99(12):4462-70. doi: 10.1210/jc.2014-3007. PMID 25238207
- BACKGROUNDDi Dalmazi G, Vicennati V, Garelli S, Casadio E, Rinaldi E, Giampalma E, Mosconi C, Golfieri R, Paccapelo A, Pagotto U, Pasquali R. Cardiovascular events and mortality in patients with adrenal incidentalomas that are either non-secreting or associated with intermediate phenotype or subclinical Cushing's syndrome: a 15-year retrospective study. Lancet Diabetes Endocrinol. 2014 May;2(5):396-405. doi: 10.1016/S2213-8587(13)70211-0. Epub 2014 Jan 29. PMID 24795253
- BACKGROUNDPatrova J, Kjellman M, Wahrenberg H, Falhammar H. Increased mortality in patients with adrenal incidentalomas and autonomous cortisol secretion: a 13-year retrospective study from one center. Endocrine. 2017 Nov;58(2):267-275. doi: 10.1007/s12020-017-1400-8. Epub 2017 Sep 8. PMID 28887710
- BACKGROUNDOlsen H, Kjellbom A, Londahl M, Lindgren O. Suppressed ACTH Is Frequently Unrelated to Autonomous Cortisol Secretion in Patients With Adrenal Incidentalomas. J Clin Endocrinol Metab. 2019 Feb 1;104(2):506-512. doi: 10.1210/jc.2018-01029. PMID 30265354
- DERIVEDKjellbom A, Lindgren O, Danielsson M, Olsen H, Londahl M. Mortality Not Increased in Patients With Nonfunctional Adrenal Adenomas: A Matched Cohort Study. J Clin Endocrinol Metab. 2023 Jul 14;108(8):e536-e541. doi: 10.1210/clinem/dgad074.