Clinical trial: A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia (NCT00796783)

Eligibility criteria:
Inclusion Criteria:

          -  Are at least 18 years of age.

          -  Have a presumptive diagnosis of Cushing's disease (Cushing's syndrome due to an ACTH
             secreting pituitary tumor).

          -  Have previously had pituitary surgery and/or pituitary radiation with the intent of
             curing or treating Cushing's disease.

          -  Have clinical symptoms and signs of hypercortisolism.

          -  Are able to provide written informed consent.

          -  Are expected to complete the study.

        Exclusion Criteria:

          -  Are surgical candidates for pituitary surgery or have had pituitary surgery within 8
             weeks before screening.

          -  Have taken any medication that may interfere with protocol testing procedures within
             30 days of initial screening (phenobarbital, phenytoin, carbamazepine, oxcarabazepine,
             primidone, rifampin, rifapentine, rifabutin, ethosuximide, pioglitazone, efavirenz,
             neviparine, modafinil, St. Johns wort, glucorticoids, estrogen containing oral
             contraceptives).

          -  Have received investigational treatment (drug, biologic agent or device) within 30
             days of screening.

          -  Have a non-endogenous source of hypercortisolemia such as factitious hypercortisolemia
             (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factitious or
             therapeutic use of ACTH.

          -  Have Pseudo-Cushing's syndrome. Subjects with suspected Pseudo-Cushing's syndrome such
             as those with severe obesity, major depression or a history of alcoholism.

          -  Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.

          -  Have renal failure as defined by a serum creatinine of 202 mg/dL.

          -  Elevated total bilirubin (>1.5x ULN), elevated ALT(>3x ULN) or AST (>3x ULN).
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