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
  Purpose

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.


Condition Intervention
Adrenal Tumour With Mild Hypercortisolism
Procedure: Adrenalectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adrenalectomy Versus Follow-up in Patients With Mild Hypercortisolism: a Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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



Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: Adrenalectomy
Adrenalectomy (open or laparoscopic)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246739

Contacts
Contact: Anders OJ Bergenfelz, MD, PhD +4646172086 anders.bergenfelz@med.lu.se
Contact: Erik Nordenström, MD, PhD +4646172305 erik.nordenstrom@skane.se

Locations
Sweden
Skåne University Hospital-Lund, Department of Surgery Recruiting
Lund, Sweden, 22185
Sub-Investigator: Erik Nordenström, MD, PhD         
Sub-Investigator: Martin Almqvist, MD, PhD         
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Anders OJ Bergenfelz, MD, PhD Department of Surgery, Skåne University Hospital, Lund, Sweden
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01246739     History of Changes
Other Study ID Numbers: 2010/297
Study First Received: November 18, 2010
Last Updated: July 5, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
mild hypercortisolism
adrenal tumour
surgical procedures, elective
indication

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Cushing Syndrome
Adrenocortical Hyperfunction
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 16, 2014