Cardiac Steatosis in Cushing's Syndrome (CORTICOEUR)

September 28, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • AP-HP, Bicêtre Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Before and after Treatment
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 Names:
  • Once
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 Names:
  • Before and after Treatment
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 Names:
  • Once
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 and 6 month after treatment
Other Names:
  • Before and after Treatment
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 Names:
  • Once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed twice in patients - before and 6 months after treatment - and once in volunteers

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Assessed twice in patients - before and 6 months after treatment - and once in volunteers
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
Assessed twice in patients - before and 6 months after treatment - and once in volunteers
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)
Assessed twice in patients - before and 6 months after treatment - and once in volunteers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Philippe CHANSON, MD, PhD, AP-HP, Bicêtre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

July 28, 2014

First Posted (ESTIMATE)

July 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOR12017
  • 2013-A01023-42 (OTHER: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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