Clinical trial · Interventional
Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome
Adrenalectomy Versus Follow-up in Patients With Mild Hypercortisolism: a Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
Incidental findings of adrenal tumours,"incidentalomas", occur in 1-5 % in the general population and 10-25 % of these patients will exhibit biochemical mild hypercortisolism. Although the patients do not have clinical signs of classical Cushing's syndrome, they have an increased risk for hypertension, dyslipidemia, diabetes mellitus, osteoporosis and obesity. The hypothesis of the study is, that surgery of the adrenal adenoma responsible for the increased secretion of cortisol, will in part cure or ameliorate the metabolic syndrome.
Conditions
Conditions (1)
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 Tumour With Mild Hypercortisolism | Adrenal Gland Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adrenalectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Follow-up
- description
- Patients who are diagnosed with biochemically mild hypercortisolism (so-called subclinical Cushing´s syndrome), who are followed only.
- type
- EXPERIMENTAL
- label
- Surgery
- description
- Patients diagnosed with adrenal tumour and with biochemically mild hypercortisolism (so-called subclinical Cushing´s syndrome), operated with adrenalectomy
- interventionNames
- Procedure: Adrenalectomy
Primary outcomes (1)
- measure
- Improvement of blood pressure as assessed by 24 hours blood pressure measurement
- timeFrame
- At two years after intervention
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adrenal tumour with biochemical mild hypercortisolism defined as pathological dexamethasone suppression test (cortisol \> 50 nmol/L at 8.00 am after 1 mg dexamethasone at 10 pm, plus one of the following criteria * Low or suppressed adrenocorticotropic hormone (ACTH) * Low or suppressed dehydroepiandrosterone (DHEA) * No or pathological circadian rhythm of cortisol Exclusion Criteria: * Increased levels of 24 hours urinary excretion of cortisol * Pregnancy or lactation * Inability to understand information or to comply with scheduled follow-up * Mild hypercortisolism with bilateral adrenal tumours, without a gradient (lateralization on venous sampling)
References
Publications (1)
- DERIVEDUeland GA, Ragnarsson O, Heie A, Kjellbom A, Lindgren O, Muth A, Palazzo F, Poulsen PL, Rolighed L, Thordarson HB, Wernig F, Bergenfelz A. Randomized trial studying metabolic outcomes and quality of life after adrenalectomy versus conservative management for mild autonomous cortisol secretion. Endocr Connect. 2025 Jul 19;14(7):e250361. doi: 10.1530/EC-25-0361. Print 2025 Jul 1. PMID 40600855