Hypercortisolism and Epicardial Adipose Tissue

Not Applicable

Completed

• Conditions: Hypercortisolism
• Interventions: Biological: Blood samples for measuring adiponectin, leptin and omentin plasma; Device: MRI at 3 Tesla

• Registration Number: NCT02335996
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-08
• Study First Submitted: 2015-01-02
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Primary Completion: 2017-06-23
• Status Verified: 2023-05
• Study Completion: 2023-05-25
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients in remission of their hypercortisolism after surgery	Blood samples for measuring adiponectin, leptin and omentin plasma	-
patients with active hypercortisolism	Blood samples for measuring adiponectin, leptin and omentin plasma	-
patients with active hypercortisolism	MRI at 3 Tesla	-
Patients in remission of their hypercortisolism after surgery	MRI at 3 Tesla	-

Primary Outcome Measures

Name	Time	Method
Assess cardiovascular risk by a blood complete lipid profile	36 months
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

Secondary Outcome Measures

Name	Time	Method
Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level	36 months
Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level	36 months

Trial Locations

Locations (1)

Assistance Publique Hôpitaux Marseille; 🇫🇷 Marseille, France