Clinical trial: Study of Cushing's Syndrome Not Related to ACTH Production (NCT00006278)

Eligibility criteria:
PATIENTS WITH NORMAL ADRENAL GLANDS:

        Patients with normal adrenal glands will be recruited from those studied under NCI
        protocols.

        They will not have taken suppressive doses of glucocorticoids for 12 months, and will not
        have any known adrenal pathology, either of the cortex or medulla.

        They will not have Von-Hippel Lindau syndrome.

        PATIENTS WITH ACTH-INDEPENDENT CUSHING'S SYNDROME:

        Will be aged 18 or older;

        Will have plasma ACTH levels of 10 pg/mL or less;

        Will have an outside physician who will follow them after surgery.

        Must not weigh greater than 380 pounds. These patients are unable to undergo CT scans.

        Must not have a CT scan showing normal or atrophic bilateral adrenal glands.

        Must not have a CRH test showing a response as defined above. The diagnosis of these
        patients will need further evaluation.

        Must not have any condition that would preclude surgery, including advanced heart failure,
        significant coronary artery disease, severe pulmonary disease.

        Must not have a hematocrit less than 30 or research blood withdraw greater than 450 mL in
        the previous six weeks.

        Must not be pregnant.

        Must not have a history of angina or known coronary artery disease, because these patients
        are at risk for exacerbation during the vasopressin test.

        The SF-36 questionnaire will only be given to individuals who speak and read English
        fluently. Patients may participate in the remainder of the study, however, if they do not
        meet this criterion.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



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