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Hyper-Cor: Hypercortisolism and Epicardial Adipose Tissue

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT02335996
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
36
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood samples for measuring adiponectin, leptin and omentin plasma
  • Device: MRI at 3 Tesla
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function
Study Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: patients with active hypercortisolism

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.
Active Comparator: Patients in remission of their hypercortisolism after surgery

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.

Outcome Measures

Primary Outcome Measures

  1. measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla. [36 months]

  2. Assess insulin resistance by the blood sugar and insulin levels [36 months]

  3. Assess cardiovascular risk by a blood complete lipid profile [36 months]

Secondary Outcome Measures

  1. Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level [36 months]

  2. Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hôpitaux Marseille Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle DESALBRES, Director, Asistance Publique Hôpitaux Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT02335996
Other Study ID Numbers:
  • 2014-23
  • 2014-A01302-45
  • RCAPHM14_0343
First Posted:
Jan 12, 2015
Last Update Posted:
Sep 1, 2017
Last Verified:
Aug 1, 2017
Additional relevant MeSH terms:
Cushing Syndrome
Adrenocortical Hyperfunction

Study Results

No Results Posted as of Sep 1, 2017