Clinical Trial: In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man
Brief 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
Detailed Summary:
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.
Sponsor: University Hospital, Bordeaux
Current 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]The secondary outcome wille be assessed by a measurement of plasma concentration of AEA, OEA and PEA during the circadian rhythm of ACTH/cortisol.
- 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, 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
- 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, OEA and PEA during the circadian rhythm of ACTH/cortisol
Original Secondary Outcome: Same as current
Information By: University Hospital, Bordeaux
Dates:
Date Received: August 30, 2016
Date Started: February 2012
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016