Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome (AUSC)
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ClinicalTrials.gov Identifier: NCT01246739 |
Recruitment Status
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Recruiting
First Posted
: November 23, 2010
Last Update Posted
: January 16, 2018
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Tracking Information | |||||||||
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First Submitted Date ICMJE | November 18, 2010 | ||||||||
First Posted Date ICMJE | November 23, 2010 | ||||||||
Last Update Posted Date | January 16, 2018 | ||||||||
Study Start Date ICMJE | June 2011 | ||||||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Improvement of blood pressure [ Time Frame: At two years after intervention ] Blood pressure as 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:
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Original Primary Outcome Measures ICMJE |
Normalization of hypertension [ Time Frame: At two years after intervention ] Normalization of hypertension according to classification of the World Health Organization (WHO) assessed by 24 hours blood pressure measurement.
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Change History | Complete list of historical versions of study NCT01246739 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome | ||||||||
Official Title ICMJE | Adrenalectomy Versus Follow-up in Patients With Mild Hypercortisolism: a Prospective Randomized Controlled Trial | ||||||||
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. |
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Detailed Description | Adrenal incidentalomas, adrenal tumours detected without symptoms and signs of hormonal hypersecretion or malignancy, are common. Depending on modality (MRI, CT. Ultrasonography) adrenal tumours occur in approximately 1-5% of the population. In about 10% of patients, the tumours are bilateral. At autopsy studies adrenal tumours occur in 1% of patients under the age of 30, but in approximately 7% of patients older than 70 years. Investigation of the adrenal tumours focus on to exclude malignancy (which is uncommon), and an increased secretion of hormones (adrenaline, aldosterone, cortisol), so-called functional tumours. However, most often adrenal incidentalomas are non-functional. The most common functional disorder is increased secretion of cortisol, and then usually without clinical stigmata, known as subclinical Cushing's syndrome (or mild hypercortisolism). Clinical stigmata, Cushing's syndrome, is empirically associated with elevated levels of urinary cortisol. Subclinical Cushing's syndrome occurs in 10-25% of patients with adrenal incidentalomas. The incidence has been estimated at 0.8 / 1,000 inhabitants, making it a common disease. Diagnosis is based to detect an autonomous release of cortisol from the adrenal gland (a disorder of the so-called hypothalamic-pituitary-adrenal axis). Fundamental to the diagnosis is that the secretion of cortisol is not inhibited <50 nmol / L at 8.00, after an overnight test with 1 mg of oral dexamethasone. In addition, at least one of the following criteria for disturbance of the hypothalamic-pituitary-adrenal axis is suggested to be present:
Numerous studies have shown that high blood pressure, diabetes, impaired glucose tolerance, and unfavourable lipid profile, is common in patients with subclinical Cushing's syndrome, and basically do not differ from patients with overt Cushing's syndrome. At follow-up of patients with adrenal incidentalomas, some patients exhibit intermittent mild hypersecretion of cortisol, others develop overt Cushing's syndrome (unusual) and still some patients with initially normal hypothalamic-pituitary-adrenal axis, develop a subclinical Cushing's syndrome. The aim of this study is to investigate if adrenalectomy for subclinical Cushing's syndrome (mild hypercortisolism without clinical signs), result in an improvement in cardiovascular risk factors, cardiac function, and arteriosclerosis compared to follow-up |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Adrenal Tumour With Mild Hypercortisolism | ||||||||
Intervention ICMJE | Procedure: Adrenalectomy
Adrenalectomy (open or laparoscopic) |
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Study Arms |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date | December 2022 | ||||||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Denmark, Norway, Sweden | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01246739 | ||||||||
Other Study ID Numbers ICMJE | 2010/297 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | Region Skane | ||||||||
Study Sponsor ICMJE | Region Skane | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Region Skane | ||||||||
Verification Date | January 2018 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |