Adrenal Incidentaloma Clinical Trial
Official title:
Effect of Surgical or Conservative Approach in Patients With Adrenal Incidentalomas on Cardiovascular, Metabolic, Neuropsychological and Bone Manifestations: Respective Roles of Cortisol Secretion and Glucocorticoid Sensitivity
Verified date | April 2021 |
Source | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Subclinical hypercortisolism (SH) is a status of asymptomatic hypercortisolism, frequently found in patients with adrenal adenomas (estimated prevalence: 0.8-2% after 60 years of age). Although SH may lead to diabetes, hypertension and osteoporosis, the diagnostic SH criteria and those suggesting the need of adrenalectomy are debated. Indeed, beside the cortisol secretion, the individual cortisol sensitivity may play a role in determining the SH consequences. Subjects with possible SH due to adrenal adenoma will be randomized to surgery/conservative follow up. The effects of surgery on the cardiovascular, bone, metabolic complications of SH and on neuropsychological aspects and quality of life (QoL) and the possibility to predict them by using cortisol sensitivity and secretion markers will be studied. The study may clarify how to individuate patients who can benefit from surgery. These results will help reducing the costs of both useless surgical operations and SH consequences.
Status | Active, not recruiting |
Enrollment | 61 |
Est. completion date | December 8, 2022 |
Est. primary completion date | February 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - unilateral adrenal incidentaloma larger than 1 cm - cortisol after 1-mg overnight dexamethasone suppression test (1mgDST) between 1.8 and 5 mcg/dl Exclusion Criteria: - hypogonadism, thyrotoxicosis, chronic renal failure and hepatic disease, alcoholism, eating, rheumatologic or hematological disorders; - intake of drugs influencing cortisol and dexamethasone metabolism or cortisol secretion; - signs of hypercortisolism (moon facies, striae rubrae, easy bruising); - possible metastatic disease or radiologic features not consistent with adrenocortical adenoma at computed tomography (CT); - pheochromocytoma and aldosteronoma; - non-adrenal SH. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Casa Sollievo della Sofferenza IRCCS, Istituto Ortopedico Galeazzi, Ministry of Health, Italy |
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | variation of blood pressure | To assess the variation of blood pressure ambulatory systolic and diastolic blood pressure (BP, mmHg), and antihypertensive treatment at baseline and follow-up will be assessed; BP will be considered improved or worsened if the non-hypertensive patients passed from a pre-hypertension category to another or the hypertensive patients from a hypertension grade to another in accordance to giudelines, of if if antihypertensive treatment was reduced by 50% | 6 months | |
Primary | variation of glucose levels | To assess the variation of glucose levels, fasting glucose levels and glucose levels after oral glucose tolerance test will be evaluated at baseline and follow-up. Glucose levels will be considered improved or worsened if fasting glucose levels pass from a category to another, following the Adult Treatment Panel III criteria or if antidiabetic treatment was reduced by 50% | 6 months | |
Primary | variation of lipids | At baseline and follow up triglyceride levels; total cholesterol levels, HDL and LDL levels (mg/dl) will be evaluated. Dyslipidemia will be diagnosed in the presence of triglyceride levels >150 mg/dl or high-density lipoprotein (HDL) cholesterol levels <40 or 50 mg/dl in males and females. dyslipidemia will be defined improved or worsened if cholesterol levels pass from a category to another, following the Adult Treatment Panel III criteria | 6 months | |
Primary | variation of body weight | At baseline and follow up body weight (kilograms) will be evaluated. the improvement/worsening during follow-up will be defined in the presence of a >5% BW decrease/increase | 6 months | |
Primary | variation of bone mineral density (BMD) | To assess the variation of bone mineral density at baseline and follow-up a Dual-energy X-ray absorptiometry (DXA) scan will be performed | 24 months | |
Primary | occurrence of vertebral fractures | A dorso-lumbar spine x-ray to evaluate the presence of morphometric fractures (presence/absence) will be performed | 24 months | |
Primary | variation of intimal medial thickness | To assess the variation of vascular damage a supra-aortic trunk echo-Doppler to evaluate at baseline and follow-up variations of intimal medial thickness will be performed | 12 months | |
Primary | variation of Relative wall thickness (RWT) | the variation of Relative wall thickness (RWT) will be evaluated by an echocardiography. It will be calculated from Left ventricular end diastolic dimension (LVEDD) (mm); Interventricular septal end diastole (IV Sd, mm) and Posterior wall thickness at end-diastole (PWd) parameters (mm) | 12 months | |
Primary | variation of Sheehan Disability Scale | Sheehan Disability Scale will be evaluated to assess perceived stress (SDS-stress scale ranges 1-10, a higher score means higher levels of stress) | 6 months | |
Primary | Cognitive evaluation by Brief Assessment Cognition in Schizophrenia (BACS) score | BACS evaluate verbal memory score (normal if >33); working memory (normal if >14.9); verbal fluency (normal if >31.6), symbol coding (normal if >40.5), tower of london (>12.4) | 6 months | |
Secondary | cortisol secretion and sensitivity | To correlate the effect of the surgical and conservative approach in relation to the degree of cortisol secretion and sensitivity we will evaluate the GR polymorphisms of N363S, BclI and ER22/23EK ,midnight salivary cortisol (MSalC) and urinary free cortisone (UFCo) levels and the UFC/UFCo ratio (index of 11HSD2 activity) | 24 months | |
Secondary | variation of Inflammation markers and bone metabolism markers | irisine, Tumor Necrosing Factor (TNF)- alpha, interleukin (IL)-6, adiponectin, resistin, sclerostin, Dickkopf-related protein (DKK) 1, N-terminal propeptide of type 1 collagen (P1NP) , monocytechemoattractant protein 1 (CCL2/MCP-1) levels will be assessed (pg/ml). Paired samples T-test will be used to compare baseline and follow-up levels. | 6 months |
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