Cushing's SyndromeVISECANCT02889224
In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man
A study testing Obese, Hypercortisolism and Hydrocortisone in people with Cushing's Syndrome, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in the pathophysiology of Cushing's syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing's Syndrome
- What is being tested?
- Obese, Hypercortisolism and Hydrocortisone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Sep 2013
- 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
- For all patients groups:
- Age ≥ 18,
- Social security.
- " Hypercortisolism " group:
- 18 < BMI < 40 kg/m2,
- Cushing's syndrome in front of :
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- impaired 1 mg dexamethasone test (08:00 A.M. cortisol > 50 nmol/L)
- qualitative and quantitative disrupted circadian rhythm of cortisol with increased plasma concentrations
- free urinary cortisol upper normal range (90 µg/24H),
- Hypercortisolism that can be treated with surgery (adrenal adenoma treated with adrenalectomy or Cushing disease treated with pituitary surgery).
- " Obese " group:
- Obese patients: 30 < BMI < 40 kg/m2,
- Normal HPA axis function:
- 08:00 A.M. cortisol > 250 nmol/L and peak above 550 nmol/L after 1 mg SST,
- Normal 24H free urinary cortisol and dexamethasone test. " Control " group:
- Lean or overweight patients (18 < BMI < 30 kg/m2),
- Non cortisol secreting pituitary or adrenal tumor,
- Patient in whom a biological evaluation of the HPA axis is recommended.
- " Hydrocortisone " group:
- Lean or overweight patients (18 < BMI < 30 kg/m2),
- Primary or secondary adrenal insufficiency,
- With a need for hydrocortisone supplementation.
Who cannot join
- Patients with eating disorders, major depressive disorders or psychiatric disorders other than Cushing's syndrome,
- Cannabis consumption, alcoholism or drug addiction,
- Active smoking,
- cortisone treatment other than hydrocortisone,
- Pregnancy or feeding,
- Surgery for obesity,
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- Incapability,
- Pathology that is life-threatening in the short term,
- Any situation that interfere with study or is risked for patient.
Trial locations and contacts
1 site in 1 country.
About this study
Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in the pathophysiology of Cushing's syndrome.
The investigators speculate that:
- acute or chronic variations in plasma cortisol may induce changes in the activity of the ECS
- that there is a circadian rhythm of the ECS driven by the rythm of plasma cortisol
Read the detailed description
The study aim to identify the relationship between the ECS and the HPA axis in humans with a main objective to assess if Cushing's syndrome induces changes in the ECS activity.
For this purpose:
- the investigors will compare plasma levels of ECS between obese controls and patients with Cushing's syndrome
- the investigors will compare plasma levels of ECS in patients with Cushing's syndrome before and immediately after curative surgery
- the investigors will compare plasma levels of ECS in patients with hypoadrenalism before and after the intake of substitutive doses of hydrocortisone
- the investigors will evaluate the plasma levels of ECS during a short synacthen test in healthy subjects.
- Conditions
- Cushing's Syndrome
- Being tested
- Obese, Hypercortisolism, Hydrocortisone, Control
- Keywords
- Obesity, Cortisol, Hydrocortisone, Endocannabinoïds
- Medical subject headings
- Cushing Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObeseOther
HypercortisolismProcedure or surgery
HydrocortisoneOther
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Obese | Active comparator | Subjects with BMI between 30 - 40 kg/m2 and no alteration of corticotrope axis. Receives: Other: Obese |
| Hypercortisolism | Experimental | Subject with BMI between 18 - 40 kg/m2 and presenting a hypercortisolism defined by HAS (Haute Autorité de Santé). Receives: Procedure: Hypercortisolism |
| Hydrocortisone | Experimental | Subject with BMI between 18 - 30 kg/m2 and with adrenal or corticotrope failure Receives: Other: Hydrocortisone |
| Control | Experimental | Subject with BMI between 18 - 30 kg/m2 and with a pituitary or adrenal tumor without effect on corticotrope axis. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluctuations of 2-AG (2-arachidonoyl-Glycérol) plasma concentration in relationship to cortisol plasma concentration in obese arm compare to hypercortisolism arm.
The primary outcome will be assessed by a measurement of plasma concentration of 2-AG during the circadian rhythm of ACTH/cortisol.
Measured: Baseline
Secondary outcomes (3)
Measurement of plasma concentration of AEA (Anandamide), OEA (Oleoyl-EthanolAmide) and PEA (Palmitoyl-EthanolAmide) endocannabinoïds associated with variations of plasma cortisol in hypercortisolism arm
The secondary outcome wille be assessed by a measurement of plasma concentration of AEA, OEA and PEA during the circadian rhythm of ACTH/cortisol.
Measured: Baseline and day 6
Measurement of plasma concentration of AEA (Anandamide), OEA (Oleoyl-EthanolAmide) and PEA (Palmitoyl-EthanolAmide) endocannabinoïds associated with variations of plasma cortisol in hydrocortisone arm
Measurement of plasma concentration of AEA, OEA and PEA on 07:30 A.M. ± 1 hour (fasting), 08:00 A.M. ± 1 hour (fasting), 09:00 A.M. ± 1 hour, 10:00 A.M. ± 1 hour, 04:00 P.M. ± 1 hour
Measured: Baseline
Measurement of plasma concentration of AEA (Anandamide), OEA (Oleoyl-EthanolAmide) and PEA (Palmitoyl-EthanolAmide) endocannabinoïds in control arm who have no cortisol production problem.
Measurement of plasma concentration of AEA, OEA and PEA during the circadian rhythm of ACTH/cortisol
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing's SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul PEREZ, MD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889224
- Sponsor's protocol ID
- CHUBX 2010/34
- Other IDs
- 2010-A01008-31
- Acronym
- VISECA
- Status last verified
- Oct 2018
- First submitted
- 30 Aug 2016
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man
- ClinicalTrials.gov ID
- NCT02889224
- Acronym / sponsor ID
- VISECA / CHUBX 2010/34
- Conditions
- Cushing's Syndrome
- Keywords
- Obesity, Cortisol, Hydrocortisone, Endocannabinoïds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Sep 2016 (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.
Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in the pathophysiology of Cushing's syndrome.
The investigators speculate that:
- acute or chronic variations in plasma cortisol may induce changes in the activity of the ECS
- that there is a circadian rhythm of the ECS driven by the rythm of plasma cortisol
Detailed description
The study aim to identify the relationship between the ECS and the HPA axis in humans with a main objective to assess if Cushing's syndrome induces changes in the ECS activity.
For this purpose:
- the investigors will compare plasma levels of ECS between obese controls and patients with Cushing's syndrome
- the investigors will compare plasma levels of ECS in patients with Cushing's syndrome before and immediately after curative surgery
- the investigors will compare plasma levels of ECS in patients with hypoadrenalism before and after the intake of substitutive doses of hydrocortisone
- the investigors will evaluate the plasma levels of ECS during a short synacthen test in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese | Active comparator | Other: ObeseSubjects with BMI between 30 - 40 kg/m2 and no alteration of corticotrope axis. |
| Hypercortisolism | Experimental | Procedure: HypercortisolismSubject with BMI between 18 - 40 kg/m2 and presenting a hypercortisolism defined by HAS (Haute Autorité de Santé). |
| Hydrocortisone | Experimental | Other: HydrocortisoneSubject with BMI between 18 - 30 kg/m2 and with adrenal or corticotrope failure |
| Control | Experimental | Other: ControlSubject with BMI between 18 - 30 kg/m2 and with a pituitary or adrenal tumor without effect on corticotrope axis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥ 18,
- Social security.
- 18 < BMI < 40 kg/m2,
- Cushing's syndrome in front of :
- impaired 1 mg dexamethasone test (08:00 A.M. cortisol > 50 nmol/L)
Key exclusion criteria (9 listed)
- Patients with eating disorders, major depressive disorders or psychiatric disorders other than Cushing's syndrome,
- Cannabis consumption, alcoholism or drug addiction,
- Active smoking,
- cortisone treatment other than hydrocortisone,
- Pregnancy or feeding,
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 |
|---|---|---|
| Obese | Other | Obese |
| Hypercortisolism | Procedure or surgery | Hypercortisolism |
| Hydrocortisone | Other | Hydrocortisone |
| Control | Other | Control |
Primary outcome
Fluctuations of 2-AG (2-arachidonoyl-Glycérol) plasma concentration in relationship to cortisol plasma concentration in obese arm compare to hypercortisolism arm.
Time frame: Baseline
The primary outcome will be assessed by a measurement of plasma concentration of 2-AG during the circadian rhythm of ACTH/cortisol.
3 secondary outcomes
Measurement of plasma concentration of AEA (Anandamide), OEA (Oleoyl-EthanolAmide) and PEA (Palmitoyl-EthanolAmide) endocannabinoïds associated with variations of plasma cortisol in hypercortisolism arm
Time frame: Baseline and day 6
Measurement of plasma concentration of AEA (Anandamide), OEA (Oleoyl-EthanolAmide) and PEA (Palmitoyl-EthanolAmide) endocannabinoïds associated with variations of plasma cortisol in hydrocortisone arm
Time frame: Baseline
Measurement of plasma concentration of AEA (Anandamide), OEA (Oleoyl-EthanolAmide) and PEA (Palmitoyl-EthanolAmide) endocannabinoïds in control arm who have no cortisol production problem.
Time frame: Baseline
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 22 May 2026.
- Individual participant dataSharing planned: No
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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.
Paul PEREZ, MD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obese, Hypercortisolism and Hydrocortisone in people with Cushing's Syndrome, run by University Hospital, Bordeaux 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 22 inclusion and 9 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 22 May 2026. 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?
Fluctuations of 2-AG (2-arachidonoyl-Glycérol) plasma concentration in relationship to cortisol plasma concentration in obese arm compare to hypercortisolism arm. (time frame: Baseline). 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 22 May 2026.