Hair Cortisol and Cushing's Disease (HAIRCUSH)
Cushing Disease
About this trial
This is an interventional diagnostic trial for Cushing Disease focused on measuring UFC, LNSC, Hair cortisol, medical treatment
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
Sites / Locations
- Service d'Endocrinologie - CHU Caen
- Service d'endocrinologie - HCL
- Service d'Endocrinologie, Diabète et Maladies Métaboliques - APHM
- CIC d'Endocrinologie, Maladies Métaboliques et Nutrition - CHU de Nantes
- Service d'Endocrinologie - APHP Cochin
- Service d'Endocrinologie et des Maladies de la Reproduction - APHP Bicêtre
- Service d'endocirnologie, diabète, nutrition, Hôpital Haut Lévêque - CHU de Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Patient group
Remission control group
Bilateral surrenalectomy control group