Clinical trial: Hair Cortisol and Cushing's Disease (NCT04201444)

Eligibility criteria:
Inclusion Criteria:

        In the three groups:

          -  Age > 18

          -  Cushing's disease medical history: histology confirming an ACTH staining adenoma, or
             ACTH-dependant Cushing syndrome with MRI confirmation of pituitary adenoma, or
             pituitary secretion of ACTH confirmed with petrosal sinus gradient

          -  Written informed consent

          -  Hair length ≥ 3 cm

        In patient group:

          -  Persistent CD diagnosed on usual criteria in expert centers including overt
             hypercortisolism with at least 2 UFC > 1.5 N prior to the start of medical treatment

          -  Previous treatment with pasireotide, cabergoline, metyrapone, ketoconazole (alone or
             in association) AND hypercortisolism considered as controlled for at least 3 months
             based on 2 normal UFC.

        In remission control group:

        o Patients cured of CD and having recovered a normal pituitary function for at least 12
        months following pituitary surgery (normal UFC associated to: cortisol suppression
        following dexamethasone suppression test, or normal LNSC, or midnight serum cortisol < 200
        nmol/L)

        In bilateral surrenalectomy control group:

        o Patients with previous CD, treated with bilateral adrenalectomy and receiving weight
        adjusted doses of hydrocortisone for at least 6 months. Last daily dose of Hydrocortisone
        should be administered no later than 5 pm.

        Exclusion Criteria:

        In the three groups:

          -  Renal Failure (Cl < 30 mL/min)

          -  Non-compliant patients

          -  Hair length < 3 cm

          -  Severe depression and psychosis

          -  Drug addiction and active alcoholism

          -  Myocardial infarction or cerebrovascular accident < 3 months

          -  Intense physical activity (marathon runner)

          -  Night-shifters

          -  Obesity with BMI > 35 kg/m2

          -  Type 1 diabetes

          -  Type 2 diabetes with HbA1C > 9 %

        In patient group:

          -  Patients receiving mifepristone and/or mitotane

          -  Patients treated with anticortisolic agents during the titration process

          -  Patients requiring additional hydrocortisone supplementation or exogenous
             corticosteroids

          -  Pituitary radiotherapy < 5 years
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? Contradiction