CompletedNot Applicable

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

France40 participantsStarted 2012-02

Plain-language 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. 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 lif…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fluctuations of 2-AG (2-arachidonoyl-Glycérol) plasma concentration in relationship to cortisol plasma concentration in obese arm compare to hypercortisolism arm.

Timeframe: Baseline

Trial details

NCT IDNCT02889224

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09

View on ClinicalTrials.gov More Cushing's Syndrome trials