Clinical trial
Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function
Name
2014-23
Description
Identifying hypercortisolism patients at risk for cardio-vascular events despite biological cure, and determine which patients should be particularly followed. Hypercortisolic patients represent an ideal in vivo model to determine the interactions between glucocorticoids and ectopic fat development.
Trial arms
Trial start
2014-12-08
Estimated PCD
2017-06-23
Trial end
2023-05-25
Status
Completed
Treatment
Blood samples for measuring adiponectin, leptin and omentin plasma
Arms:
Patients in remission of their hypercortisolism after surgery, patients with active hypercortisolism
MRI at 3 Tesla
Evaluation by MRI at 3 Tesla of the amount of ectopic fat heart, liver and pancréas and bone marrow.
Arms:
Patients in remission of their hypercortisolism after surgery, patients with active hypercortisolism
Size
43
Primary endpoint
measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla.
36 months
Assess insulin resistance by the blood sugar and insulin levels
36 months
Assess cardiovascular risk by a blood complete lipid profile
36 months
Eligibility criteria
Inclusion Criteria:
* Major, male or female
* Introducing an active or healed hypercortisolism caused by Cushing's disease
* signed informed consent.
Exclusion Criteria:
* Elderly patients under 18 years
* Pregnant or lactating women
* Previous history of myocardial infarction
* Antecedent congenital cardiomyopathy
* Adrenocorticotropic hormone-independent Hyperadrenocorticism
* Hyperadrenocorticism by ectopic Adrenocorticotropic hormone secretion
* Treatment with corticosteroids or insulin
* Specific contraindication to the achievement of Nuclear Magnetic Resonance (metal heart valves, pacemakers, metallic foreign body, claustrophobia)
* Persons deprived of liberty
* Persons not affiliated to a social security scheme
* People unable to give their consent in writing (in person or with the assistance of a third party).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}
Updated at
2023-05-26
1 organization
1 product
1 indication
Organization
Assistance Publique Hopitaux De MarseilleIndication
Cushing's syndrome