Clinical trial: In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man (NCT02889224)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the office due to weight gain and fatigue.  He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father.  Blood pressure is 165/90 mm Hg and pulse is 85/min.  On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities.  Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit.  Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels.  Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome.

Patient description (patient's own words): I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome.

Does the patient match the trial criteria? 1