In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02889224
• Date of registration: 30/08/2016
• Prospective Registration: No
• Primary sponsor: University Hospital, Bordeaux
• Public title: In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man VISECA
• Scientific title: In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man
• Date of first enrolment: February 2012
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02889224
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Paul PEREZ, MD
• Affiliation: University Hospital, Bordeaux

Key inclusion & exclusion criteria

Inclusion Criteria:

For all patients groups:

- Age = 18,

- Social security.

" Hypercortisolism " group:

- 18 < BMI < 40 kg/m2,

- Cushing's syndrome in front of :

- 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.

Exclusion Criteria:

- 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,

- Incapability,

- Pathology that is life-threatening in the short term,

- Any situation that interfere with study or is risked for patient.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cushing's Syndrome

Intervention(s)

Other: Hydrocortisone

Other: Control

Procedure: Hypercortisolism

Other: Obese

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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 associated with variations of plasma cortisol in hypercortisolism arm [Time Frame: Baseline and day 6]

Secondary ID(s)

CHUBX 2010/34

Source(s) of Monetary Support

Please refer to primary and secondary sponsors