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Trial record 44 of 115 for:    cancer | butyrate

Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA)

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ClinicalTrials.gov Identifier: NCT04127552
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea M. Isidori, University of Roma La Sapienza

Brief Summary:
The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 ECE guidelines, can improve metabolic parameters and cardiovascular risks and features.

Condition or disease Intervention/treatment
Adrenal Incidentaloma Hypercortisolism Adrenal Tumor Procedure: Adrenalectomy

Detailed Description:

Adrenal incidentalomas are clinically silent masses discovered inadvertently during diagnostic imaging procedures performed for unrelated reasons. Depending on the criteria applied, up to 50% of patients with adrenal incidentalomas may have biochemical evidence of cortisol excess. Possible autonomous cortisol secretion (pACS), as defined in the 2016 European Society of Endocrinology Guidelines, is characterized by a partial, incomplete suppression of the hypothalamic-pituitary-adrenal (HPA) axis without the typical signs of overt cortisol hypersecretion.

Investigators will perform a prospective longitudinal study in patients with adrenal incidentalomas associated with possible autonomous cortisol secretion, aiming to assess the effect of surgical and conservative management on cardiovascular and metabolic features.

Data will be detected at baseline, at 1 and at 5 years follow-up to quantitatively identify the different cardiovascular and metabolic alterations in: (1) patients with non-functioning adrenal adenoma; (2) patients with possible autonomous cortisol secretion receiving conservative management; (3) patients with possible autonomous cortisol secretion receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines; (4) patients without adrenal masses.


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Study Type : Observational
Estimated Enrollment : 68 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : March 31, 2025


Group/Cohort Intervention/treatment
Patients with non-functioning adrenal adenoma
Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels lower than 50 nmol/L
Patients with pACS receiving conservative management
Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving conservative management
Patients with pACS receiving adrenalectomy
Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines
Procedure: Adrenalectomy
Adrenalectomy accordint to 2016 ESE guidelines

Healthy controls
Patients without adrenal masses



Primary Outcome Measures :
  1. Echocardiographic Change of Left Ventricular Hypertrophy [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Change of Left Ventricular Hypertrophy will be evaluated by transtoracic echocardiography. Patients will be examined in the left lateral decubitus position according to the American Society of Echocardiography guidelines.


Secondary Outcome Measures :
  1. Change of arterial stiffness and blood pressure using brachial oscillometric blood pressure waves for a noninvasive estimation. [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Perform non-invasive measurement of arterial stiffness

  2. Change of blood pressure using ambulatory blood pressure monitoring blood pressure waves for a noninvasive estimation. [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Perform twenty-four-hour systolic and diastolic ambulatory blood pressure monitoring

  3. Change in blood Coagulation Tests [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Perform blood sampling for coagulative function

  4. Change in Dual X-Ray Absorptiometry T-score [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Bone mineral density change in spine and femur

  5. Radiological evaluation of adrenal mass [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Perform adrenal chemical shift MRI or adrenal CT scan (if MRI is contraindicated)

  6. Evaluation of sleep disturbances using questionnaire (PSQI) [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Perform the Pittsburgh Sleep Quality Index (PSQI). Sleep disturbances will be evaluated by The Pittsburgh Sleep Quality Index (PSQI). This questionnaire contains 19 self-related questions which are combined to create 7 component scores with a range of 0-3 points (0:no difficulty, 3: severe difficulty). Global score is the result to the addition of all component scores with a range of 0-21 points (0:no difficulty, 21: severe difficulty).

  7. Infectious diseases frequency and severity with modified German Diseases Questionnaire [ Time Frame: Baseline (T0), after 1 year (t1) and 5 years (t2) ]

    Frequencies and severity of infectious diseases will be evaluated by modified Infectious Diseases Questionnaire (GNC).

    This questionnaire includes questions on infectious diseases of upper and lower respiratory tract, gastrointestinal tract, skin and urogenital tract and flu contracted during the previous 12 months. Questions investigate on the number and duration of infections, necessity of antibiotic or antifungal therapy, hospital stay and days of absence from work. Final score represents the frequency of infections.


  8. Quality of life: SF-36-Item Health Survey questionnaire [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]

    Quality of life will be evaluated by the Physical Component score and the Mental Component score of the self-administered questionnaire SF-36-Item Health Survey questionnaire.

    This questionnaire measures eight scales: physical functioning, role physical, bodily pain, general health (physical component) and vitality, social functioning, role emotional, mental health (mental component).

    Interpretation of the score will be the following: at each item of the questionnaire corresponds a percentage value (from 0% to 100%). The average of the single items constitutes the scale total percentage (from 0% to 100%); missing data are not considered during calculation. High score defines a more favorable health state.


  9. Psychometric Evaluation: Beck Depression Inventory questionnaire [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Psychometric evaluation will be assessed by the score of Beck depression Index: a 21-item measure of depressive symptoms. Each answer is scored on a scale value (from 0 to 3 points). The global score is obtained adding all single scores, with a range of 0-63. Higher score constitutes worse burden of symptoms (0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression).

  10. Evaluation of sexual dysfunction using FSFI questionnaire in woman [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Perform the Female Sexual Function Index (FSFI) questionnaire. This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.

  11. Evaluation of sexual dysfunction using IIEF questionnaire in man [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Perform the International Index of Erectile Function (IIEF) questionnaire in man. The IIEF is an internationally validated test. It is used to assign a score of erectile dysfunction: severe score 1 to 10; moderate score 11 to 16; low to moderate score 17 to 21; Low score 22 to 25; no erectile dysfunction score 26 to 30

  12. Change in insuline resistance calculated with HOMA index [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Measurement of HOMA index calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.

  13. Change in measurement of weight [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Measurement of body weight (kg)

  14. Change in blood lipid profile [ Time Frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2) ]
    Measurement of Total Cholesterol, LDL cholesterol, HDL cholesterol, Triglyceredes



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-functioning adrenal incidentalomas or adrenal incidentalomas associated with possible autonomous cortisol secretion (subclinical hypercortisolism)
Criteria

Inclusion Criteria:

  • Incidentally detected adrenal mass

Exclusion Criteria:

  • Patients with overt Cushing's syndrome, pheocromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage
  • Patients taking medications influencing glucocorticoid production or metabolism
  • Patients with psychiatric diseases or alcohol abuse
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127552


Locations
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Italy
Department of Experimental Medicine Recruiting
Rome, Italy, 00161
Contact: Andrea M Isidori, MD, PhD    +390649970711    andrea.isidori@uniroma1.it   
Sub-Investigator: Marianna Minnetti         
Sub-Investigator: Emilia Sbardella         
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Andrea M Isidori, MD, PHD Sapienza

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Responsible Party: Andrea M. Isidori, Full Professor of Endocrinology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04127552     History of Changes
Other Study ID Numbers: ITACA
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Cortex Neoplasms
Hydrocortisone 17-butyrate 21-propionate
Adrenocortical Adenoma
Cushing Syndrome
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Adrenal Cortex Diseases
Hydrocortisone
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents