Back to resultsHypercortisolism and Epicardial Adipose Tissue (Hyper-Cor)
Primary Purpose
Hypercortisolism
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples for measuring adiponectin, leptin and omentin plasma
MRI at 3 Tesla
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypercortisolism
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).
Sites / Locations
- Assistance Publique Hôpitaux Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
patients with active hypercortisolism
Patients in remission of their hypercortisolism after surgery
Arm Description
Outcomes
Primary Outcome Measures
measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla.
Assess insulin resistance by the blood sugar and insulin levels
Assess cardiovascular risk by a blood complete lipid profile
Secondary Outcome Measures
Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level
Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level
Full Information
NCT ID
NCT02335996
First Posted
January 2, 2015
Last Updated
May 25, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02335996
Brief Title
Hypercortisolism and Epicardial Adipose Tissue
Acronym
Hyper-Cor
Official Title
Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2014 (Actual)
Primary Completion Date
June 23, 2017 (Actual)
Study Completion Date
May 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercortisolism
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with active hypercortisolism
Arm Type
Active Comparator
Arm Title
Patients in remission of their hypercortisolism after surgery
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Blood samples for measuring adiponectin, leptin and omentin plasma
Intervention Type
Device
Intervention Name(s)
MRI at 3 Tesla
Intervention Description
Evaluation by MRI at 3 Tesla of the amount of ectopic fat heart, liver and pancréas and bone marrow.
Primary Outcome Measure Information:
Title
measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla.
Time Frame
36 months
Title
Assess insulin resistance by the blood sugar and insulin levels
Time Frame
36 months
Title
Assess cardiovascular risk by a blood complete lipid profile
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level
Time Frame
36 months
Title
Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES, Director
Organizational Affiliation
Asistance Publique Hôpitaux Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Hypercortisolism and Epicardial Adipose Tissue
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