Hypercortisolism and Epicardial Adipose Tissue

Hypercortisolism Clinical Trial

— Hyper-Cor  

Official title:

Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335996
• Other study ID #: 2014-23
• Secondary ID: 2014-A01302-45RC
• Status: Completed
• Phase: N/A
• Start date: December 8, 2014
• Est. completion date: May 25, 2023

Study information

• Verified date: May 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 25, 2023
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adrenocortical Hyperfunction
• Cushing Syndrome
• Hypercortisolism

Intervention

Biological:
• Blood samples for measuring adiponectin, leptin and omentin plasma

Device:
• MRI at 3 Tesla
Evaluation by MRI at 3 Tesla of the amount of ectopic fat heart, liver and pancréas and bone marrow.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla.		36 months
Primary	Assess insulin resistance by the blood sugar and insulin levels		36 months
Primary	Assess cardiovascular risk by a blood complete lipid profile		36 months
Secondary	Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level		36 months
Secondary	Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level		36 months