Hypercortisolism and Epicardial Adipose Tissue (Hyper-Cor)

May 25, 2023 updated by: Assistance Publique Hopitaux De Marseille

Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13354
        • ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla.
Time Frame: 36 months
36 months
Assess insulin resistance by the blood sugar and insulin levels
Time Frame: 36 months
36 months
Assess cardiovascular risk by a blood complete lipid profile
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level
Time Frame: 36 months
36 months
Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2014

Primary Completion (Actual)

June 23, 2017

Study Completion (Actual)

May 25, 2023

Study Registration Dates

First Submitted

January 2, 2015

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimated)

January 12, 2015

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-23
  • 2014-A01302-45 (Registry Identifier: ANSM)
  • RCAPHM14_0343 (Other Identifier: APHM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypercortisolism

Clinical Trials on Blood samples for measuring adiponectin, leptin and omentin plasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe