NCT02335996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

January 2, 2015

Last Update Submit

May 25, 2023

Conditions

Hypercortisolism

Outcome Measures

Primary Outcomes (3)

  • measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla.

    36 months

  • Assess insulin resistance by the blood sugar and insulin levels

    36 months

  • Assess cardiovascular risk by a blood complete lipid profile

    36 months

Secondary Outcomes (2)

  • Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level

    36 months

  • Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level

    36 months

Study Arms (2)

patients with active hypercortisolism

ACTIVE COMPARATOR
Biological: Blood samples for measuring adiponectin, leptin and omentin plasmaDevice: MRI at 3 Tesla

Patients in remission of their hypercortisolism after surgery

ACTIVE COMPARATOR
Biological: Blood samples for measuring adiponectin, leptin and omentin plasmaDevice: MRI at 3 Tesla

Interventions

Blood samples for measuring adiponectin, leptin and omentin plasmaBIOLOGICAL
Patients in remission of their hypercortisolism after surgerypatients with active hypercortisolism
MRI at 3 TeslaDEVICE

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 surgerypatients with active hypercortisolism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major, male or female
  • Introducing an active or healed hypercortisolism caused by Cushing's disease
  • signed informed consent.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Cushing Syndrome

Interventions

Blood Specimen CollectionLeptin

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesAdipokinesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Urielle DESALBRES, Director

    Asistance Publique Hôpitaux Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2015

First Posted

January 12, 2015

Study Start

December 8, 2014

Primary Completion

June 23, 2017

Study Completion

May 25, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations

FR(1)