Endocrine System DiseaseCORTICOEURNCT02202902
Cardiac Steatosis in Cushing's Syndrome
A study testing 1H magnetic resonance spectroscopy and CMRI in people with Endocrine System Disease and Cardiovascular Imaging, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine System Disease, Cardiovascular Imaging
- What is being tested?
- 1H magnetic resonance spectroscopy and CMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- contraindication of MRI
- hypersensitivity to gadolinium
- acute myocardial ischemia
- renal insufficiency (creatinin clearance 30 mL/min/l,73m2)
- pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, 94275
Peter KAMENICKY, MD, +33 (0)1 45 21 37 06, peter.kamenicky@bct.aphp.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Endocrine System Disease, Cardiovascular Imaging
- Being tested
- 1H magnetic resonance spectroscopy and CMRI
- Keywords
- Cushing's syndrome, cardiac steatosis, intramyocardial triglyceride content, 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, Left Ventricularly hypertrophy
- Medical subject headings
- Endocrine System Diseases, Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1H magnetic resonance spectroscopy and CMRIOther
Also called Before and after Treatment
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 CMRIOther
Also called Once
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : 1H magnetic resonance spectroscopy and CMRI | Experimental | Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance Receives: Other: 1H magnetic resonance spectroscopy and CMRI |
| Group 2 : 1H magnetic resonance spectroscopy and CMRI | Experimental | Group 2: Cushing's syndrome patients with normal glucose intolerance Receives: Other: 1H magnetic resonance spectroscopy and CMRI |
| Group 3 : 1H magnetic resonance spectroscopy and CMRI | Experimental | age-, sex- and BMI-matched healthy volunteers Receives: Other: 1H magnetic resonance spectroscopy and CMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio
Intramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy
Measured: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
Secondary outcomes (3)
Left Ventricular intramyocardial fatt fraction (Dixon)
In/Out of Phase Imaging (Dixon)
Measured: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
Subcutaneous and visceral abdominal fatt
ISubcutaneous and visceral abdominal fat masses were determined from abdominal axial images at the L3 to L4 level
Measured: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
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)
Measured: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endocrine System DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CHANSON, MD, PhD, Principal investigator, AP-HP, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202902
- Sponsor's protocol ID
- AOR12017
- Other IDs
- 2013-A01023-42
- Acronym
- CORTICOEUR
- Status last verified
- Sep 2016
- First submitted
- 25 Jul 2014
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolf P, Marty B, Bouazizi K, Kachenoura N, Piedvache C, Blanchard A, Salenave S, Prigent M, Jublanc C, Ajzenberg C, Droumaguet C, Young J, Lecoq AL, Kuhn E, Agostini H, Trabado S, Carlier PG, Feve B, Redheuil A, Chanson P, Kamenicky P. Epicardial and Pericardial Adiposity Without Myocardial Steatosis in Cushing Syndrome. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3505-3514. doi: 10.1210/clinem/dgab556.
PubMed 34333603
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Steatosis in Cushing's Syndrome. A 1H-Magnetic Resonance Spectroscopy Study
- ClinicalTrials.gov ID
- NCT02202902
- Acronym / sponsor ID
- CORTICOEUR / AOR12017
- Conditions
- Endocrine System Disease, Cardiovascular Imaging
- Keywords
- Cushing's syndrome, cardiac steatosis, intramyocardial triglyceride content, 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, Left Ventricularly hypertrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 : 1H magnetic resonance spectroscopy and CMRI | Experimental | Other: 1H magnetic resonance spectroscopy and CMRIGroup 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance |
| Group 2 : 1H magnetic resonance spectroscopy and CMRI | Experimental | Other: 1H magnetic resonance spectroscopy and CMRIGroup 2: Cushing's syndrome patients with normal glucose intolerance |
| Group 3 : 1H magnetic resonance spectroscopy and CMRI | Experimental | Other: 1H magnetic resonance spectroscopy and CMRIage-, sex- and BMI-matched healthy volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- contraindication of MRI
- hypersensitivity to gadolinium
- acute myocardial ischemia
- renal insufficiency (creatinin clearance 30 mL/min/l,73m2)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1H magnetic resonance spectroscopy and CMRIAlso: Before and after TreatmentMetabolic 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 | Group 1 : 1H magnetic resonance spectroscopy and CMRI, Group 2 : 1H magnetic resonance spectroscopy and CMRI |
| 1H magnetic resonance spectroscopy and CMRIAlso: OnceMetabolic 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 | Group 3 : 1H magnetic resonance spectroscopy and CMRI |
Primary outcome
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
3 secondary outcomes
Left Ventricular intramyocardial fatt fraction (Dixon)
Time frame: 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
Cardiac morphology and function
Time frame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Derived from this study: PubMed 34333603Wolf P, Marty B, Bouazizi K, Kachenoura N, Piedvache C, Blanchard A, Salenave S, Prigent M, Jublanc C, Ajzenberg C, Droumaguet C, Young J, Lecoq AL, Kuhn E, Agostini H, Trabado S, Carlier PG, Feve B, Redheuil A, Chanson P, Kamenicky P. Epicardial and Pericardial Adiposity Without Myocardial Steatosis in Cushing Syndrome. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3505-3514. doi: 10.1210/clinem/dgab556.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe CHANSON, MD, PhD principal investigator
AP-HP, Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1H magnetic resonance spectroscopy and CMRI in people with Endocrine System Disease and Cardiovascular Imaging, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe CHANSON, MD, PhD (+33 (0)1 45 21 37 05, philippe.chanson@bct.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.