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Cardiac Steatosis in Cushing's Syndrome (CORTICOEUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202902
Recruitment Status : Unknown
Verified September 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : July 29, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients compared to healthy subjects present with excess lipid storage in cardiac myocytes, reversible upon correction of hypercortisolism.

Condition or disease Intervention/treatment Phase
Endocrine System Disease Cardiovascular Imaging Other: 1H magnetic resonance spectroscopy and CMRI Not Applicable

Detailed Description:
Despite skeletal muscle atrophy, Cushing's syndrome patients have an increased Left Ventricular mass, reversible upon correction of the hypercortisolism. This may be due to cardiac steatosis, previously demonstrated in patients with diabetes mellitus. This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging (CMRI), in patients with Cushing's syndrome and in age-, sex- and BMI-matched healthy volunteers. The patients will be stratified into two groups in function of the presence or absence of diabetes mellitus or impaired glucose and will be evaluated twice: before and 6 months after efficient treatment of Cushing's syndrome. We make the hypothesis that Cushing's syndrome patients compared to healthy subjects have excess lipid storage in cardiac myocytes irrespectively of the glucose homeostasis status, and that this lipid content will decrease after the correction of hypercortisolism.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Cardiac Steatosis in Cushing's Syndrome. A 1H-Magnetic Resonance Spectroscopy Study
Study Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1 : 1H magnetic resonance spectroscopy and CMRI
Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance
 Other: 1H magnetic resonance spectroscopy and CMRI
Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before and 6 month after treatment
Other Name: Before and after Treatment
Experimental: Group 2 : 1H magnetic resonance spectroscopy and CMRI
Group 2: Cushing's syndrome patients with normal glucose intolerance
 Other: 1H magnetic resonance spectroscopy and CMRI
Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before and 6 month after treatment
Other Name: Before and after Treatment
Experimental: Group 3 : 1H magnetic resonance spectroscopy and CMRI
age-, sex- and BMI-matched healthy volunteers
 Other: 1H magnetic resonance spectroscopy and CMRI
Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before treatment
Other Name: Once


Outcome Measures
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Primary Outcome Measures :
  1. Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio [ Time Frame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers ]
    Intramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy


Secondary Outcome Measures :
  1. Left Ventricular intramyocardial fatt fraction (Dixon) [ Time Frame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers ]
    In/Out of Phase Imaging (Dixon)

  2. Subcutaneous and visceral abdominal fatt [ Time Frame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers ]
    ISubcutaneous and visceral abdominal fat masses were determined from abdominal axial images at the L3 to L4 level

  3. Cardiac morphology and function [ Time Frame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers ]
    LV mass index, LA, LV and Right Ventricular (RV) ejection fractions and LV and RV stroke volumes assessed by Cardiac Magnetic Resonance Imaging (CMRI)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • group 1 and 2: patients with overt Cushing's syndrome, with 24-hour urinary free cortisol excretion over the two fold of the upper limit of the normal, with (group 1) or without (group 2) diabetes mellitus or glucose intolerance
  • group 3: healthy volunteers matched for age, sex and BMI with the patients of the group 2

Exclusion Criteria:

  • contraindication of MRI
  • hypersensitivity to gadolinium
  • acute myocardial ischemia
  • renal insufficiency (creatinin clearance 30 mL/min/l,73m2)
  • pregnancy
Contacts and Locations
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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): NCT02202902


Contacts
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Contact: Philippe CHANSON, MD, PhD +33 (0)1 45 21 37 05 philippe.chanson@bct.aphp.fr
Contact: Peter KAMENICKY, MD +33 (0)1 45 21 37 06 peter.kamenicky@bct.aphp.fr

Locations
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France
AP-HP, Bicêtre Hospital Recruiting
Le Kremlin-Bicêtre, France, 94275
Contact: Peter KAMENICKY, MD    +33 (0)1 45 21 37 06    peter.kamenicky@bct.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Philippe CHANSON, MD, PhD AP-HP, Bicêtre Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02202902    
Other Study ID Numbers: AOR12017
2013-A01023-42 ( Other Identifier: IDRCB )
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cushing's syndrome
cardiac steatosis
intramyocardial triglyceride content
1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging
Left Ventricularly hypertrophy
Additional relevant MeSH terms:
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Fatty Liver
Cushing Syndrome
Endocrine System Diseases
Liver Diseases
 Digestive System Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases