Cardiac Steatosis in Cushing's Syndrome

Endocrine System Disease Clinical Trial

— CORTICOEUR  

Official title:

Evaluation of Cardiac Steatosis in Cushing's Syndrome. A 1H-Magnetic Resonance Spectroscopy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02202902
• Other study ID #: AOR12017
• Secondary ID: 2013-A01023-42
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2014
• Last updated: September 28, 2016
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe CHANSON, MD, PhD
• Phone: +33 (0)1 45 21 37 05
• Email: philippe.chanson[@]bct.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiovascular Imaging
• Cushing Syndrome
• Endocrine System Disease
• Endocrine System Diseases
• Fatty Liver
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
France	AP-HP, Bicêtre Hospital	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio	Intramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy	Assessed twice in patients - before and 6 months after treatment - and once in volunteers	No
Secondary	Left Ventricular intramyocardial fatt fraction (Dixon)	In/Out of Phase Imaging (Dixon)	Assessed twice in patients - before and 6 months after treatment - and once in volunteers	No
Secondary	Subcutaneous and visceral abdominal fatt	ISubcutaneous and visceral abdominal fat masses were determined from abdominal axial images at the L3 to L4 level	Assessed twice in patients - before and 6 months after treatment - and once in volunteers	No
Secondary	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)	Assessed twice in patients - before and 6 months after treatment - and once in volunteers	No