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Completed

NCT Number: NCT02335996

Hypercortisolism and Epicardial Adipose Tissue

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.

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Key information

Conditions

Hypercortisolism Adrenal Gland Diseases Adrenocortical Hyperfunction Cushing Syndrome Endocrine System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood samples for measuring adiponectin, leptin and omentin plasma

Biological

MRI at 3 Tesla

Device

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

Primary outcomes

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

    Time frame: 36 months

  2. Assess insulin resistance by the blood sugar and insulin levels

    Time frame: 36 months

  3. Assess cardiovascular risk by a blood complete lipid profile

    Time frame: 36 months

Secondary outcomes

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

    Time frame: 36 months

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

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function

Acronym: Hyper-Cor

Important dates

Study start
2014
Primary completion
2017
Study completion
2023
First posted
Jan 12, 2015
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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