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Cardiac Steatosis in Cushing's Syndrome (CORTICOEUR)

This study is currently recruiting participants.
Verified September 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT02202902
First Posted: July 29, 2014
Last Update Posted: September 29, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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 Intervention
Endocrine System Disease Cardiovascular Imaging Other: 1H magnetic resonance spectroscopy and CMRI

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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:
  • 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)

  • 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

  • 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)


Estimated Enrollment: 60
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
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
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
Principal Investigator: Philippe CHANSON, MD, PhD AP-HP, Bicêtre Hospital
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02202902     History of Changes
Other Study ID Numbers: AOR12017
2013-A01023-42 ( Other Identifier: IDRCB )
First Submitted: July 25, 2014
First Posted: July 29, 2014
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:
Fatty Liver
Cushing Syndrome
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases