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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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