An interventional study of Adrenalectomy in Adrenal Tumour With Mild Hypercortisolism, sponsored by Region Skane. Terminated at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
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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.
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
62 studies on the registry are indexed under Adrenal Gland Neoplasms; 19 are open to participants now.
This study's enrollment of 34 is close to the median of 37 across 33 interventional studies indexed under Adrenal Gland Neoplasms.
Browse Adrenal Gland Neoplasms studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
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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
Exclusion Criteria:
Patients who are diagnosed with biochemically mild hypercortisolism (so-called subclinical Cushing´s syndrome), who are followed only.
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)
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.
Time frame: At two years after intervention
Normalization of diabetes mellitus
Normalization of diabetes mellitus according to the criteria of the World Health Organization and assessed by oral glucose tolerance test
Time frame: At two years after intervention
Decreased body mass index (BMI) to < 30
Standard assessment of BMI
Time frame: At two years post intervention
Bone density
Bone density assessed with dual energy x-ray absorptiometry (DEXA) at the lumbar spine and hip
Time frame: At two years post intervention
Blood lipids
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)
Time frame: At two years post intervention
Cardiac function
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)
Time frame: At two years post intervention
Cognitive function
Mini Mental State Examination (MMSE) for cognitive function
Time frame: At two years after intervention
Quality of Life assessed by SF 36
Quality of Life assessed by the generic instrument short form 36 (SF-36).
Time frame: At two years after intervention
Atherosclerosis
Carotid ultrasound/duplex scans with evaluation of intimal thickness and plaques. Blood pressure measurement for ankle index
Time frame: At two years after intervention
Adrenal cortical insufficiency
Rate of patients with postoperative adrenal cortical insufficiency in patients operated due to subclinical Cushings syndrome
Time frame: At two years after intervention
The record gives a start of Jun 2011, a primary completion of Feb 2024 and a completion of Feb 2024. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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