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Cardiac Steatosis in Cushing's Syndrome

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02202902
Acronym
CORTICOEUR
Enrollment
60
Registered
2014-07-29
Start date
2014-06-30
Completion date
2017-12-31
Last updated
2016-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Imaging, Endocrine System Disease

Keywords

Cushing's syndrome, cardiac steatosis, intramyocardial triglyceride content, 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, Left Ventricularly hypertrophy

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.

Interventions

OTHER1H 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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratioAssessed twice in patients - before and 6 months after treatment - and once in volunteersIntramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy

Secondary

MeasureTime frameDescription
Left Ventricular intramyocardial fatt fraction (Dixon)Assessed twice in patients - before and 6 months after treatment - and once in volunteersIn/Out of Phase Imaging (Dixon)
Subcutaneous and visceral abdominal fattAssessed twice in patients - before and 6 months after treatment - and once in volunteersISubcutaneous and visceral abdominal fat masses were determined from abdominal axial images at the L3 to L4 level
Cardiac morphology and functionAssessed twice in patients - before and 6 months after treatment - and once in volunteersLV mass index, LA, LV and Right Ventricular (RV) ejection fractions and LV and RV stroke volumes assessed by Cardiac Magnetic Resonance Imaging (CMRI)

Countries

France

Contacts

Primary ContactPhilippe CHANSON, MD, PhD
philippe.chanson@bct.aphp.fr+33 (0)1 45 21 37 05
Backup ContactPeter KAMENICKY, MD
peter.kamenicky@bct.aphp.fr+33 (0)1 45 21 37 06

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026