Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04860180
Other study ID # RF-2013-02356606
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 29, 2016
Est. completion date December 8, 2022

Study information

Verified date April 2021
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Intervention

Procedure:
adrenalectomy


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Casa Sollievo della Sofferenza IRCCS, Istituto Ortopedico Galeazzi, Ministry of Health, Italy

References & Publications (16)

See more »

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT03919734 - Morbidity and Mortality in Autonomous Cortisol Secretion
Recruiting NCT05357456 - Performances on Cognitive Functions and Brain Function and Follow-up After Different Treatments in Patients With Autonomous Cortisol Secretion: a Single-center, Prospective, Observational Study
Enrolling by invitation NCT03474237 - A Prospective Cohort Study for Patients With Adrenal Diseases
Completed NCT04682938 - The Prevalence and Characteristics of Adrenal Incidentaloma
Recruiting NCT04890444 - China Adrenal Disease Registry
Recruiting NCT04616703 - Natural History of NFAI: 10 Year Follow-up Results
Recruiting NCT04328181 - Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT) N/A
Recruiting NCT02324647 - Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
Recruiting NCT04127552 - Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
Active, not recruiting NCT04917757 - Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas
Completed NCT01949714 - Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue
Recruiting NCT05237817 - Association Between Stroke and Adrenal Incidentalomas
Recruiting NCT04833192 - Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism