search
Back to results

Cardiac Steatosis in Cushing's Syndrome (CORTICOEUR)

Primary Purpose

Endocrine System Disease, Cardiovascular Imaging

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
1H magnetic resonance spectroscopy and CMRI
1H magnetic resonance spectroscopy and CMRI
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endocrine System Disease focused on measuring Cushing's syndrome, cardiac steatosis, intramyocardial triglyceride content, 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, Left Ventricularly hypertrophy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AP-HP, Bicêtre HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1 : 1H magnetic resonance spectroscopy and CMRI

Group 2 : 1H magnetic resonance spectroscopy and CMRI

Group 3 : 1H magnetic resonance spectroscopy and CMRI

Arm Description

Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance

Group 2: Cushing's syndrome patients with normal glucose intolerance

age-, sex- and BMI-matched healthy volunteers

Outcomes

Primary Outcome Measures

Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio
Intramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy

Secondary Outcome Measures

Left Ventricular intramyocardial fatt fraction (Dixon)
In/Out of Phase Imaging (Dixon)
Subcutaneous and visceral abdominal fatt
ISubcutaneous and visceral abdominal fat masses were determined from abdominal axial images at the L3 to L4 level
Cardiac morphology and function
LV mass index, LA, LV and Right Ventricular (RV) ejection fractions and LV and RV stroke volumes assessed by Cardiac Magnetic Resonance Imaging (CMRI)

Full Information

First Posted
July 25, 2014
Last Updated
September 28, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT02202902
Brief Title
Cardiac Steatosis in Cushing's Syndrome
Acronym
CORTICOEUR
Official Title
Evaluation of Cardiac Steatosis in Cushing's Syndrome. A 1H-Magnetic Resonance Spectroscopy Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine System Disease, Cardiovascular Imaging
Keywords
Cushing's syndrome, cardiac steatosis, intramyocardial triglyceride content, 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, Left Ventricularly hypertrophy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 : 1H magnetic resonance spectroscopy and CMRI
Arm Type
Experimental
Arm Description
Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance
Arm Title
Group 2 : 1H magnetic resonance spectroscopy and CMRI
Arm Type
Experimental
Arm Description
Group 2: Cushing's syndrome patients with normal glucose intolerance
Arm Title
Group 3 : 1H magnetic resonance spectroscopy and CMRI
Arm Type
Experimental
Arm Description
age-, sex- and BMI-matched healthy volunteers
Intervention Type
Other
Intervention Name(s)
1H magnetic resonance spectroscopy and CMRI
Other Intervention Name(s)
Before and after Treatment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
1H magnetic resonance spectroscopy and CMRI
Other Intervention Name(s)
Once
Intervention Description
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
Primary Outcome Measure Information:
Title
Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio
Description
Intramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy
Time Frame
Assessed twice in patients - before and 6 months after treatment - and once in volunteers
Secondary Outcome Measure Information:
Title
Left Ventricular intramyocardial fatt fraction (Dixon)
Description
In/Out of Phase Imaging (Dixon)
Time Frame
Assessed twice in patients - before and 6 months after treatment - and once in volunteers
Title
Subcutaneous and visceral abdominal fatt
Description
ISubcutaneous and visceral abdominal fat masses were determined from abdominal axial images at the L3 to L4 level
Time Frame
Assessed twice in patients - before and 6 months after treatment - and once in volunteers
Title
Cardiac morphology and function
Description
LV mass index, LA, LV and Right Ventricular (RV) ejection fractions and LV and RV stroke volumes assessed by Cardiac Magnetic Resonance Imaging (CMRI)
Time Frame
Assessed twice in patients - before and 6 months after treatment - and once in volunteers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe CHANSON, MD, PhD
Phone
+33 (0)1 45 21 37 05
Email
philippe.chanson@bct.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Peter KAMENICKY, MD
Phone
+33 (0)1 45 21 37 06
Email
peter.kamenicky@bct.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe CHANSON, MD, PhD
Organizational Affiliation
AP-HP, Bicêtre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP, Bicêtre Hospital
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter KAMENICKY, MD
Phone
+33 (0)1 45 21 37 06
Email
peter.kamenicky@bct.aphp.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
34333603
Citation
Wolf P, Marty B, Bouazizi K, Kachenoura N, Piedvache C, Blanchard A, Salenave S, Prigent M, Jublanc C, Ajzenberg C, Droumaguet C, Young J, Lecoq AL, Kuhn E, Agostini H, Trabado S, Carlier PG, Feve B, Redheuil A, Chanson P, Kamenicky P. Epicardial and Pericardial Adiposity Without Myocardial Steatosis in Cushing Syndrome. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3505-3514. doi: 10.1210/clinem/dgab556.
Results Reference
derived

Learn more about this trial

Cardiac Steatosis in Cushing's Syndrome

We'll reach out to this number within 24 hrs