Hypercortisolism and Epicardial Adipose Tissue

NCT ID: NCT02335996

Last Updated: 2023-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-08

Study Completion Date

2023-05-25

Brief Summary

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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

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Conditions

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Hypercortisolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients with active hypercortisolism

Group Type ACTIVE_COMPARATOR

Blood samples for measuring adiponectin, leptin and omentin plasma

Intervention Type BIOLOGICAL

MRI at 3 Tesla

Intervention Type DEVICE

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

Patients in remission of their hypercortisolism after surgery

Group Type ACTIVE_COMPARATOR

Blood samples for measuring adiponectin, leptin and omentin plasma

Intervention Type BIOLOGICAL

MRI at 3 Tesla

Intervention Type DEVICE

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

Interventions

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Blood samples for measuring adiponectin, leptin and omentin plasma

Intervention Type BIOLOGICAL

MRI at 3 Tesla

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urielle DESALBRES, Director

Role: STUDY_DIRECTOR

Asistance Publique Hôpitaux Marseille

Locations

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Assistance Publique Hôpitaux Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01302-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

RCAPHM14_0343

Identifier Type: OTHER

Identifier Source: secondary_id

2014-23

Identifier Type: -

Identifier Source: org_study_id

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