Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome (AUSC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01246739
First received: November 18, 2010
Last updated: July 5, 2013
Last verified: July 2013

November 18, 2010
July 5, 2013
June 2011
January 2015   (final data collection date for primary outcome measure)
Normalization of hypertension [ Time Frame: At two years after intervention ] [ Designated as safety issue: No ]
Normalization of hypertension according to classification of the World Health Organization (WHO) assessed by 24 hours blood pressure measurement.
Same as current
Complete list of historical versions of study NCT01246739 on ClinicalTrials.gov Archive Site
  • Normalization of diabetes mellitus [ Time Frame: At two years after intervention ] [ Designated as safety issue: No ]
    Normalization of diabetes mellitus according to the criteria of the WHO and assessed by oral glucose tolerance test
  • Decreased body mass index (BMI) to < 30 [ Time Frame: At two years post intervention ] [ Designated as safety issue: No ]
    Standard assessment of BMI
  • Bone density [ Time Frame: At two years post intervention ] [ Designated as safety issue: No ]
    Bone density assessed with dual energy x-ray absorptiometry (DEXA) at the lumbar spine and hip
  • Blood lipids [ Time Frame: At two years post intervention ] [ Designated as safety issue: No ]
    Triglyceride and cholesterol changes of whole serum and of the lipoprotein classes; low-density-lipoprotein (LDL), very-low-density-lipoprotein (VLDL) and high-density-lipoprotein (HDL)
  • Cardiac function [ Time Frame: At two years post intervention ] [ Designated as safety issue: No ]
    Cardiac function assessed by echocardiography; left ventricular ejection fraction (EF), left ventricular end-diastolic diameter (LVDD), left ventricular mass index (LVMI), ratio between mitral peak velocity flow of the early filling wave and the atrial wave (E/A ratio)
  • Cognitive function [ Time Frame: At two years after intervention ] [ Designated as safety issue: No ]
    Mini Mental State Examination (MMSE) for cognitive function
  • Quality of Life [ Time Frame: At two years after intervention ] [ Designated as safety issue: No ]
    Quality of Life assessed by the generic instrument short form 36 (SF-36).
  • Atherosclerosis [ Time Frame: At one and two years after intervention ] [ Designated as safety issue: No ]

    Carotid ultrasound/duplex scans with evaluation of intimal thickness and plaques.

    Blood pressure measurement for ankle index

Same as current
Not Provided
Not Provided
 
Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome
Adrenalectomy Versus Follow-up in Patients With Mild Hypercortisolism: a Prospective Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adrenal Tumour With Mild Hypercortisolism
Procedure: Adrenalectomy
Adrenalectomy (open or laparoscopic)
  • 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
    Intervention: Procedure: Adrenalectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
January 2015
January 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Anders OJ Bergenfelz, MD, PhD +4646172086 anders.bergenfelz@med.lu.se
Contact: Erik Nordenström, MD, PhD +4646172305 erik.nordenstrom@skane.se
Sweden
 
NCT01246739
2010/297
No
Region Skane
Region Skane
Not Provided
Principal Investigator: Anders OJ Bergenfelz, MD, PhD Department of Surgery, Skåne University Hospital, Lund, Sweden
Region Skane
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP