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Completed

NCT Number: NCT02889224

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Endocrinologie, Hopital Haut-Leveque

Pessac, 33600, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Obese

Other

Hypercortisolism

Procedure

Hydrocortisone

Other

Control

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: VISECA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2016
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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