Clinical trial: Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing's Syndrome (NCT03211624)

Eligibility criteria:
Inclusion criteria:

          -  Male and female patients with Cushing syndrome (CS) caused by ACTH-producing pituitary
             adenoma or cortisol producing adrenal adenoma

          -  Age between 18 and 65 years

        Exclusion criteria

          -  CS caused by ectopic ACTH producing tumours

          -  CS caused by adrenocortical carcinoma

          -  Pseudo CS

          -  Subclinical CS

          -  Exogenous CS

          -  Previous history of major psychiatric disorder (not related to CS)

          -  Neurological disorders affecting the central nervous system

          -  High alcohol consumption (more than 14 units of alcohol per week)

          -  Active malignancy or any treatment for malignancy during the last 2 years

          -  Heart failure (NYHC II-IV)

          -  Severe respiratory insufficiency

          -  Severely impaired hepatic function (alanine transaminase and/or aspartate transaminase
             concentrations two times the upper limit of normal or above)

          -  Severely impaired renal function (serum- creatinine >150 µmol/L or glomerular
             filtration rate <45 ml/min)

          -  Pregnancy or breast feeding

          -  Any other illness that significantly affects the patients cognitive function according
             to the investigators opinion

          -  Contraindication for MRI (Presence of medical implants, metal in the body,
             claustrophobia)
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 65 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? Entailment