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:

  1. the investigors will compare plasma levels of ECS between obese controls and patients with Cushing's syndrome
  2. the investigors will compare plasma levels of ECS in patients with Cushing's syndrome before and immediately after curative surgery
  3. the investigors will compare plasma levels of ECS in patients with hypoadrenalism before and after the intake of substitutive doses of hydrocortisone
  4. 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 ]

The primary outcome will be assessed by a measurement of plasma concentration of 2-AG during the circadian rhythm of ACTH/cortisol.


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