search
Back to results

Effect of Surgical or Conservative Approach in Patients With Adrenal Incidentalomas

Primary Purpose

Adrenal Incidentaloma, Subclinical Hypercortisolism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
adrenalectomy
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenal Incidentaloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    A, surgery

    B, observation

    Arm Description

    adrenalectomy

    conservative follow up

    Outcomes

    Primary Outcome Measures

    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%
    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%
    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
    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
    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
    occurrence of vertebral fractures
    A dorso-lumbar spine x-ray to evaluate the presence of morphometric fractures (presence/absence) will be performed
    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
    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)
    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)
    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)

    Secondary Outcome Measures

    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)
    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.

    Full Information

    First Posted
    February 16, 2021
    Last Updated
    April 22, 2021
    Sponsor
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    Collaborators
    Casa Sollievo della Sofferenza IRCCS, Istituto Ortopedico Galeazzi, Ministry of Health, Italy
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04860180
    Brief Title
    Effect of Surgical or Conservative Approach in Patients With Adrenal Incidentalomas
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 29, 2016 (Actual)
    Primary Completion Date
    February 22, 2021 (Actual)
    Study Completion Date
    December 8, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    Collaborators
    Casa Sollievo della Sofferenza IRCCS, Istituto Ortopedico Galeazzi, Ministry of Health, Italy

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Subclinical hypercortisolism (SH) is a status of asymptomatic hypercortisolism, which is present in up to the 30% of patients with incidentally discovered adrenal adenomas (adrenal incidentalomas, AI). Since AI are present in 7-10% of individuals after 60 years of age, the estimated SH prevalence in this population is 0.8-2%. In patients with SH due to an adrenal adenoma the risk of diabetes, hypertension, cardiovascular events, osteoporosis and mortality seems to be increased, and monolateral adrenalectomy beneficial. However, no randomized studies evaluated the effects of surgery on SH consequences and established the criteria indicating the need of surgery itself. Thus, in many patients the SH diagnosis is uncertain and the best approach (surgical or conservative) unknown. These uncertainties are also due to the influence of the individual glucocorticoid (GC) sensitivity. Indeed, in the single individual the various polymorphisms of GC receptor (GR) and the different 11ß-hydroxysteroid-dehydrogenase type 2 enzyme (11HSD2) activity, regulating the tissue exposure to the active GC, may differently predispose to the consequences of GC excess. Therefore, in AI patients, beside the evaluation of the degree of the cortisol hypersecretion, the assessment of the cortisol sensitivity may be useful in establishing the individual risk of SH consequences and the possible usefulness of a surgical approach. Specific Aim: In AI subjects with uncertain SH the combined evaluation of the clinical features together with the parameters of cortisol secretion and sensitivity will consent to decide which patient has the greatest probability to ameliorate after surgery. To assess the variation of blood pressure control, lipids and glucose metabolism, vascular damage, bone mineral density (BMD), clinical and morphometric vertebral fractures, body composition, coagulation parameters, neuropsychological aspects and quality of life (QoL) in AI patients with uncertain SH after the surgical removal of the adrenal mass or after a conservative treatment. To assess in AI patients and uncertain hypercortisolism the effect of the surgical and conservative approach on cardiovascular, metabolic and bone manifestations, neuropsychological aspects and quality of life (QoL), in relation to the degree of cortisol secretion and sensitivity. To establish the best clinical-biochemical criteria for diagnosing SH, on the basis of the changes of the outcomes after the surgical or conservative approach, and therefore, for addressing the treatment of choice in the individual patient with AI. Methods. During the enrollment period (24 months), all patients between 40 and 75 years of age referred for unilateral AI larger than 1 cm will be evaluated. In all subjects, adrenocorticotroph hormone (ACTH), urinary free cortisol (UFC), cortisol after 1-mg overnight dexamethasone suppression test (1mgDST) and the GR polymorphisms of N363S, BclI and ER22/23EK will be assessed. Patients with 1mgDST >1.8 mcg/dL will undergo a low dose (2 mg for 2 days) dexamethasone suppression test (LDDST). Patients with 1mgDST and LDDST >5 mcg/dL and suppressed (<5 pg/mL) ACTH levels will be excluded as affected by biochemically overt hypercortisolism, that requires surgery. AI patients with 1mgDST or LDDST <1.8 mcg/dL will be excluded as certainly not affected with SH. AI patients with AI >5 cm will leave the study as in this case surgery is mandatory. Eventually, after the enrollment period, 54 AI patients with uncertain SH will be included and randomized to surgery (Group1) or conservative treatment (Group 2). The follow-up period will last 24 months (after withdrawal of GC substitution therapy, if needed, for Group 1). Group 1 patients will undergo laparoscopic or laparotomic adrenalectomy, depending on the AI size and their clinical characteristics. Evaluations at baseline, 6, 12 and 24 months: blood pressure (BP), body weight (BW), body mass index (BMI), waist circumference, glucose, lipid and coagulation parameters, body composition and adenoma size by CT (Group 2 patients). Group 2 patients with a >1 cm adenoma increase or appearance of overt SH will leave the study. At baseline and after 24 months, bone mineral density (BMD) and quality (by trabecular bone score, TBS), vertebral fractures (VFx), carotid atherosclerosis, neuropsychological aspects and QoL, will be assessed. The patients will be defined: i) obese, in the presence of BMI >30 kg/m2; ii) hypertensive in the presence of systolic BP >130 mmHg and/or diastolic BP >85 mmHg and/or any antihypertensive treatment; iii) diabetic, in the presence of the World Health Organization criteria, and/or any hypoglycemic drug, iv) dyslipidemic, 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, respectively. The improvement/worsening during follow-up will be defined as follows: for obesity in the presence of a >5% BW decrease/increase, for hypertension if the non-hypertensive patients passed from a pre-hypertension category to another or the hypertensive patients from a hypertension grade to another; for diabetes and dyslipidemia if fasting glucose and cholesterol levels pass from a category to another, respectively, following the Adult Treatment Panel III criteria. The efficacy of the surgical and conservative approach on the basis of the changes of BP, BW, glucose and lipid control, BMD, VFx incidence (primary outcomes) will be compared. The effect of surgery on the coagulation parameters, carotid atherosclerosis, body composition, neuropsychological aspects and QoL (secondary outcomes) will be also evaluated. At baseline, and at 6, 12 and 24 months, beside ACTH, 1mgDST and UFC, the midnight salivary cortisol (MSalC) and urinary free cortisone (UFCo) levels and the UFC/UFCo ratio (index of 11HSD2 activity) will be assessed In Group 1 and Group 2 patients the association between the changes of the primary and secondary outcomes with the cortisol secretion parameters and the presence/absence of GC sensitizing GR polymorphisms and the degree of 11HSD2 activity, will be evaluated. An algorithm for predicting the effect of the surgical or conservative approach on the primary outcomes in the individual AI patient with uncertain SH. The algorithm, based on the combination of the SH complications at baseline (hypertension, osteoporotic fractures, diabetes) with the presence/absence of GC sensitizing GR polymorphisms, degree of 11HSD2 activity and parameters of cortisol secretion, will be retrospectively tested on the study population, will be elaborated. This would consent to evaluate positive and negative predictive value of the algorithm for predicting the response to surgery in the individual patient with AI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adrenal Incidentaloma, Subclinical Hypercortisolism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    61 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A, surgery
    Arm Type
    Experimental
    Arm Description
    adrenalectomy
    Arm Title
    B, observation
    Arm Type
    No Intervention
    Arm Description
    conservative follow up
    Intervention Type
    Procedure
    Intervention Name(s)
    adrenalectomy
    Primary Outcome Measure Information:
    Title
    variation of blood pressure
    Description
    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%
    Time Frame
    6 months
    Title
    variation of glucose levels
    Description
    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%
    Time Frame
    6 months
    Title
    variation of lipids
    Description
    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
    Time Frame
    6 months
    Title
    variation of body weight
    Description
    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
    Time Frame
    6 months
    Title
    variation of bone mineral density (BMD)
    Description
    To assess the variation of bone mineral density at baseline and follow-up a Dual-energy X-ray absorptiometry (DXA) scan will be performed
    Time Frame
    24 months
    Title
    occurrence of vertebral fractures
    Description
    A dorso-lumbar spine x-ray to evaluate the presence of morphometric fractures (presence/absence) will be performed
    Time Frame
    24 months
    Title
    variation of intimal medial thickness
    Description
    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
    Time Frame
    12 months
    Title
    variation of Relative wall thickness (RWT)
    Description
    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)
    Time Frame
    12 months
    Title
    variation of Sheehan Disability Scale
    Description
    Sheehan Disability Scale will be evaluated to assess perceived stress (SDS-stress scale ranges 1-10, a higher score means higher levels of stress)
    Time Frame
    6 months
    Title
    Cognitive evaluation by Brief Assessment Cognition in Schizophrenia (BACS) score
    Description
    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)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    cortisol secretion and sensitivity
    Description
    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)
    Time Frame
    24 months
    Title
    variation of Inflammation markers and bone metabolism markers
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Iacopo Chiodini, Professor
    Organizational Affiliation
    Istituto Auxologico Italiano
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10732263
    Citation
    Reincke M. Subclinical Cushing's syndrome. Endocrinol Metab Clin North Am. 2000 Mar;29(1):43-56. doi: 10.1016/s0889-8529(05)70115-8.
    Results Reference
    background
    PubMed Identifier
    15850851
    Citation
    Terzolo M, Bovio S, Reimondo G, Pia A, Osella G, Borretta G, Angeli A. Subclinical Cushing's syndrome in adrenal incidentalomas. Endocrinol Metab Clin North Am. 2005 Jun;34(2):423-39, x. doi: 10.1016/j.ecl.2005.01.008.
    Results Reference
    background
    PubMed Identifier
    19549741
    Citation
    Chiodini I, Morelli V, Masserini B, Salcuni AS, Eller-Vainicher C, Viti R, Coletti F, Guglielmi G, Battista C, Carnevale V, Iorio L, Beck-Peccoz P, Arosio M, Ambrosi B, Scillitani A. Bone mineral density, prevalence of vertebral fractures, and bone quality in patients with adrenal incidentalomas with and without subclinical hypercortisolism: an Italian multicenter study. J Clin Endocrinol Metab. 2009 Sep;94(9):3207-14. doi: 10.1210/jc.2009-0468. Epub 2009 Jun 23.
    Results Reference
    background
    PubMed Identifier
    24423350
    Citation
    Morelli V, Reimondo G, Giordano R, Della Casa S, Policola C, Palmieri S, Salcuni AS, Dolci A, Mendola M, Arosio M, Ambrosi B, Scillitani A, Ghigo E, Beck-Peccoz P, Terzolo M, Chiodini I. Long-term follow-up in adrenal incidentalomas: an Italian multicenter study. J Clin Endocrinol Metab. 2014 Mar;99(3):827-34. doi: 10.1210/jc.2013-3527. Epub 2014 Jan 1.
    Results Reference
    background
    PubMed Identifier
    24795253
    Citation
    Di Dalmazi G, Vicennati V, Garelli S, Casadio E, Rinaldi E, Giampalma E, Mosconi C, Golfieri R, Paccapelo A, Pagotto U, Pasquali R. Cardiovascular events and mortality in patients with adrenal incidentalomas that are either non-secreting or associated with intermediate phenotype or subclinical Cushing's syndrome: a 15-year retrospective study. Lancet Diabetes Endocrinol. 2014 May;2(5):396-405. doi: 10.1016/S2213-8587(13)70211-0. Epub 2014 Jan 29.
    Results Reference
    background
    PubMed Identifier
    19906240
    Citation
    Manenschijn L, van den Akker EL, Lamberts SW, van Rossum EF. Clinical features associated with glucocorticoid receptor polymorphisms. An overview. Ann N Y Acad Sci. 2009 Oct;1179:179-98. doi: 10.1111/j.1749-6632.2009.05013.x.
    Results Reference
    background
    PubMed Identifier
    19207316
    Citation
    Szappanos A, Patocs A, Toke J, Boyle B, Sereg M, Majnik J, Borgulya G, Varga I, Liko I, Racz K, Toth M. BclI polymorphism of the glucocorticoid receptor gene is associated with decreased bone mineral density in patients with endogenous hypercortisolism. Clin Endocrinol (Oxf). 2009 Nov;71(5):636-43. doi: 10.1111/j.1365-2265.2009.03528.x. Epub 2009 Jan 22.
    Results Reference
    background
    PubMed Identifier
    15466942
    Citation
    Tomlinson JW, Walker EA, Bujalska IJ, Draper N, Lavery GG, Cooper MS, Hewison M, Stewart PM. 11beta-hydroxysteroid dehydrogenase type 1: a tissue-specific regulator of glucocorticoid response. Endocr Rev. 2004 Oct;25(5):831-66. doi: 10.1210/er.2003-0031.
    Results Reference
    background
    PubMed Identifier
    22549969
    Citation
    Eller-Vainicher C, Morelli V, Ulivieri FM, Palmieri S, Zhukouskaya VV, Cairoli E, Pino R, Naccarato A, Scillitani A, Beck-Peccoz P, Chiodini I. Bone quality, as measured by trabecular bone score in patients with adrenal incidentalomas with and without subclinical hypercortisolism. J Bone Miner Res. 2012 Oct;27(10):2223-30. doi: 10.1002/jbmr.1648.
    Results Reference
    background
    PubMed Identifier
    18426820
    Citation
    Webb SM, Badia X, Barahona MJ, Colao A, Strasburger CJ, Tabarin A, van Aken MO, Pivonello R, Stalla G, Lamberts SW, Glusman JE. Evaluation of health-related quality of life in patients with Cushing's syndrome with a new questionnaire. Eur J Endocrinol. 2008 May;158(5):623-30. doi: 10.1530/EJE-07-0762.
    Results Reference
    background
    PubMed Identifier
    12502614
    Citation
    Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S5-20. doi: 10.2337/diacare.26.2007.s5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    11368702
    Citation
    Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.
    Results Reference
    background
    PubMed Identifier
    12457296
    Citation
    Vidal J. Updated review on the benefits of weight loss. Int J Obes Relat Metab Disord. 2002 Dec;26 Suppl 4:S25-8. doi: 10.1038/sj.ijo.0802215.
    Results Reference
    background
    PubMed Identifier
    17563527
    Citation
    Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. doi: 10.1097/HJH.0b013e3281fc975a. No abstract available. Erratum In: J Hypertens. 2007 Aug;25(8):1749.
    Results Reference
    background
    PubMed Identifier
    32154561
    Citation
    Athimulam S, Delivanis D, Thomas M, Young WF, Khosla S, Drake MT, Bancos I. The Impact of Mild Autonomous Cortisol Secretion on Bone Turnover Markers. J Clin Endocrinol Metab. 2020 May 1;105(5):1469-77. doi: 10.1210/clinem/dgaa120.
    Results Reference
    background
    PubMed Identifier
    27450696
    Citation
    Bancos I, Alahdab F, Crowley RK, Chortis V, Delivanis DA, Erickson D, Natt N, Terzolo M, Arlt W, Young WF Jr, Murad MH. THERAPY OF ENDOCRINE DISEASE: Improvement of cardiovascular risk factors after adrenalectomy in patients with adrenal tumors and subclinical Cushing's syndrome: a systematic review and meta-analysis. Eur J Endocrinol. 2016 Dec;175(6):R283-R295. doi: 10.1530/EJE-16-0465. Epub 2016 Jul 22.
    Results Reference
    background
    PubMed Identifier
    35721734
    Citation
    Morelli V, Frigerio S, Aresta C, Passeri E, Pugliese F, Copetti M, Barbieri AM, Fustinoni S, Polledri E, Corbetta S, Arosio M, Scillitani A, Chiodini I. Adrenalectomy Improves Blood Pressure and Metabolic Control in Patients With Possible Autonomous Cortisol Secretion: Results of a RCT. Front Endocrinol (Lausanne). 2022 Jun 2;13:898084. doi: 10.3389/fendo.2022.898084. eCollection 2022.
    Results Reference
    derived

    Learn more about this trial

    Effect of Surgical or Conservative Approach in Patients With Adrenal Incidentalomas

    We'll reach out to this number within 24 hrs