Cardiac Steatosis in Cushing's Syndrome

Not Applicable

• Conditions: Endocrine System Disease; Cardiovascular Imaging
• Interventions: Other: 1H magnetic resonance spectroscopy and CMRI

• Registration Number: NCT02202902
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-29
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 : 1H magnetic resonance spectroscopy and CMRI	1H magnetic resonance spectroscopy and CMRI	Group 2: Cushing's syndrome patients with normal glucose intolerance
Group 3 : 1H magnetic resonance spectroscopy and CMRI	1H magnetic resonance spectroscopy and CMRI	age-, sex- and BMI-matched healthy volunteers
Group 1 : 1H magnetic resonance spectroscopy and CMRI	1H magnetic resonance spectroscopy and CMRI	Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance

Primary Outcome Measures

Name	Time	Method
Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio	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

Name	Time	Method
Left Ventricular intramyocardial fatt fraction (Dixon)	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	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	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)

Trial Locations

Locations (1)

AP-HP, Bicêtre Hospital; 🇫🇷 Le Kremlin-Bicêtre, France