Clinical trial: Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome (NCT02297945)

Eligibility criteria:
Inclusion Criteria:

        1. Patients with endogenous Cushing's syndrome:

          -  Cushing disease patients with persistent or recurrent disease (after pituitary
             surgery) or who are newly diagnosed but are unsuitable for early surgery or wish to
             defer surgery;

          -  Patients with ectopic ACTH syndrome (either occult, after surgery failure, or
             inoperable or metastatic);

          -  Patients with Cushing's syndrome from adrenal causes

        Exclusion Criteria:

          1. Pseudo Cushing's syndrome

          2. Cyclic Cushing's syndrome defined by at least one normal UFC value among at least
             three 24-hour urinary sampling measurements over the previous 2 months

          3. Advanced adrenocortical carcinoma or ectopic ACTH secretion (EAS) secondary to a small
             cell lung carcinoma

          4. Life expectancy less than 3 months

          5. Pituitary or adrenal surgery or pituitary irradiation or surgery of the ACTH-secreting
             ectopic tumor or bilateral adrenalectomy planned before the week 12 visit

          6. Pituitary irradiation within the previous 5 years (for Cushing's disease patients)

          7. Enlarged pituitary adenoma (greater than 1 cm in vertical diameter and leaving less
             than 2 mm from the chiasma) or compression of the optic chiasma on the pituitary MRI
             for patients with Cushing's disease

          8. Severe uncontrolled hypertension (>180/110 mmHg) despite anti-hypertensive therapy
             (for otherwise eligible patients, blood pressure medication may be adjusted to meet
             this criterion)

          9. Severe hypokalemia (< 2.5 mmol/L) despite corrective measures

         10. White blood cell counts <3 x 109 /L; hemoglobin <10 g/dL; platelets <100 x 109 /L

         11. Any other severe acute or chronic medical or psychiatric condition, or laboratory
             abnormality that in the judgment of the investigator, would present excess risk
             associated with study participation or study drug administration, or which, in the
             judgment of the investigator, would make the patient inappropriate for entry into this
             study.
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? Entailment