Clinical trial: Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease (NCT02603653)

Eligibility criteria:
Inclusion Criteria:

        Patients :

          -  history of Cushing's Disease

          -  aged : 18 - 60 years

          -  Biological remission of Cushing's disease for at least one year

          -  Affiliation to Social Security

          -  Informed consent signed by patient and investigator (at the latest the inclusion's
             day, before study's exams)

        For controls :

          -  People aged 18 to 60 years matched to patients for age, sex and educational level

          -  Affiliation to Social Security

          -  Informed consent signed by patient and investigator (at the latest the inclusion's
             day, before study's exams)

        Exclusion Criteria:

        For patients :

          -  Persistent hypercortisolism (even mild)

          -  Current treatment of hypercortisolism with drugs

          -  Obesity (BMI >30 kg/m²)

          -  Alcohol or drug addiction present or past

          -  Growth hormone deficit

          -  Diabetes mellitus with hemoglobin A1c > 7.5% and/or fasting blood glucose > 1.4 g/L

          -  History of pituitary radiotherapy

          -  History of cerebrovascular or neuro-cerebral disease

          -  untreated dysthyroidism

          -  Current psychotropic drug treatment

          -  Pregnancy

          -  Use of glucocorticoids in the last 3 months before study (aside hydrocortisone
             replacement therapy)

          -  Excessive hydrocortisone replacement therapy (unadjusted to weight and/or with evening
             administration)

        For controls :

          -  Obesity (BMI >30 kg/m²)

          -  Alcohol or drug addiction present or past

          -  Current psychotropic drug treatment

          -  History of cerebrovascular or neuro-cerebral disease

          -  Current pregnancy

          -  Chronical use of corticoid (> 1 month), current or past

          -  Use of glucocorticoids in the last 3 months before study (aside hydrocortisone
             replacement therapy)

          -  Diabetes mellitus with hemoglobin A1c > 7.5% and/or fasting blood glucose > 1.4 g/L

          -  Obesity (BMI >30 kg/m²)

          -  untreated dysthyroidism
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years

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