Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome

NCT01246739 | Terminated

• 1 other identifier: 2010/297
• Study Type: interventional
• Target: 34
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Adrenal Tumour With Mild Hypercortisolism

Keywords

mild hypercortisolism; adrenal tumour; surgical procedures, elective; indication

Outcome Measures

Primary Outcomes (1)

• Improvement of blood pressure as assessed by 24 hours blood pressure measurement

  Blood pressure assessed by 24 hours measurement is considered to be improved if at least one of the following outcomes has occurred, and is sustained, during 2 years of follow-up: 1. Normalization of hypertension without medical treatment 2. Unchanged or decreased blood pressure in patients with hypertension if the number or dose of the patient's antihypertensive drug (s) has been reduced 3. Unchanged normal blood pressure in patients who were normotensive at the time of randomization.

  At two years after intervention

Secondary Outcomes (9)

• Normalization of diabetes mellitus

  At two years after intervention

• Decreased body mass index (BMI) to < 30

  At two years post intervention

• Bone density

  At two years post intervention

• Blood lipids

  At two years post intervention

• Cardiac function

  At two years post intervention

Study Arms (2)

Follow-up

NO INTERVENTION

Patients who are diagnosed with biochemically mild hypercortisolism (so-called subclinical Cushing´s syndrome), who are followed only.

Surgery

EXPERIMENTAL

Patients diagnosed with adrenal tumour and with biochemically mild hypercortisolism (so-called subclinical Cushing´s syndrome), operated with adrenalectomy

Procedure: Adrenalectomy

Interventions

Adrenalectomy PROCEDURE

Adrenalectomy (open or laparoscopic)

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Region Skane: lead

Study Sites (4)

Århus University Hospital

Aarhus, 8000, Denmark

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Skåne University Hospital-Lund, Department of Surgery

Lund, 22185, Sweden

Location

Related Publications (1)

• Ueland 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 DERIVED

MeSH Terms

Conditions

Adrenal Gland Neoplasms

Interventions

Adrenalectomy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Anders OJ Bergenfelz, MD, PhD

  Department of Surgery, Skåne University Hospital, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 23, 2010
• Study Start: June 1, 2011
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-03

Locations

NO (1); DK (1); SE (2)