Adrenalectomy Versus Follow-up in Patients With Mild Hypercortisolism: a Prospective Randomized Controlled Trial

Status: Terminated
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Århus University Hospital
Aarhus
Norway
Haukeland University Hospital
Bergen
Sweden
Sahlgrenska University Hospital
Gothenburg
Skåne University Hospital-Lund, Department of Surgery
Lund
Time Frame
Start Date: 2011-06
Completion Date: 2024-02
Participants
Target number of participants: 34
Treatments
No_intervention: Follow-up
Patients who are diagnosed with biochemically mild hypercortisolism (so-called subclinical Cushing´s syndrome), who are followed only.
Experimental: Surgery
Patients diagnosed with adrenal tumour and with biochemically mild hypercortisolism (so-called subclinical Cushing´s syndrome), operated with adrenalectomy
Related Therapeutic Areas
Sponsors
Leads: Region Skane

This content was sourced from clinicaltrials.gov