HypercortisolismHyper-CorNCT02335996
Hypercortisolism and Epicardial Adipose Tissue
A study testing Blood samples for measuring adiponectin, leptin and omentin plasma and MRI at 3 Tesla in people with Hypercortisolism, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercortisolism
- What is being tested?
- Blood samples for measuring adiponectin, leptin and omentin plasma and MRI at 3 Tesla
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2014to 25 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major, male or female
- Introducing an active or healed hypercortisolism caused by Cushing's disease
- signed informed consent.
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypercortisolism
- Being tested
- Blood samples for measuring adiponectin, leptin and omentin plasma, MRI at 3 Tesla
- Medical subject headings
- Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for measuring adiponectin, leptin and omentin plasmaBiological
MRI at 3 TeslaDevice
Evaluation by MRI at 3 Tesla of the amount of ectopic fat heart, liver and pancréas and bone marrow.
| Study group | Role | What they receive |
|---|---|---|
| patients with active hypercortisolism | Active comparator | Not described Receives: Biological: Blood samples for measuring adiponectin, leptin and omentin plasma; Device: MRI at 3 Tesla |
| Patients in remission of their hypercortisolism after surgery | Active comparator | Not described Receives: Biological: Blood samples for measuring adiponectin, leptin and omentin plasma; Device: MRI at 3 Tesla |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla.
Measured: 36 months
Assess insulin resistance by the blood sugar and insulin levels
Measured: 36 months
Assess cardiovascular risk by a blood complete lipid profile
Measured: 36 months
Secondary outcomes (2)
Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level
Measured: 36 months
Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study start8 Dec 2014
- Primary completion23 Jun 2017
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercortisolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Director, Study director, Asistance Publique Hôpitaux Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335996
- Sponsor's protocol ID
- 2014-23
- Other IDs
- 2014-A01302-45, RCAPHM14_0343
- Acronym
- Hyper-Cor
- Status last verified
- May 2023
- First submitted
- 2 Jan 2015
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function
- ClinicalTrials.gov ID
- NCT02335996
- Acronym / sponsor ID
- Hyper-Cor / 2014-23
- Conditions
- Hypercortisolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 8 Dec 2014 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with active hypercortisolism | Active comparator | Biological: Blood samples for measuring adiponectin, leptin and omentin plasma, Device: MRI at 3 Tesla |
| Patients in remission of their hypercortisolism after surgery | Active comparator | Biological: Blood samples for measuring adiponectin, leptin and omentin plasma, Device: MRI at 3 Tesla |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major, male or female
- Introducing an active or healed hypercortisolism caused by Cushing's disease
- signed informed consent.
Key exclusion criteria (11 listed)
- Elderly patients under 18 years
- Pregnant or lactating women
- Previous history of myocardial infarction
- Antecedent congenital cardiomyopathy
- Adrenocorticotropic hormone-independent Hyperadrenocorticism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for measuring adiponectin, leptin and omentin plasma | Biological | Patients in remission of their hypercortisolism after surgery, patients with active hypercortisolism |
| MRI at 3 TeslaEvaluation by MRI at 3 Tesla of the amount of ectopic fat heart, liver and pancréas and bone marrow. | Device | Patients in remission of their hypercortisolism after surgery, patients with active hypercortisolism |
Primary outcome
measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla.
Time frame: 36 months
Assess insulin resistance by the blood sugar and insulin levels
Time frame: 36 months
Assess cardiovascular risk by a blood complete lipid profile
Time frame: 36 months
2 secondary outcomes
Assess insulin resistance by the blood leptin, adiponectin and omentin plasma level
Time frame: 36 months
Assess cardiovascular risk by the blood leptin, adiponectin and omentin plasma level
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES, Director study director
Asistance Publique Hôpitaux Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples for measuring adiponectin, leptin and omentin plasma and MRI at 3 Tesla in people with Hypercortisolism, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring the volume of epicardial adipose tissue, as measured by MRI to 3 Tesla. (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.