Clinical trial: Jugular Vein Sampling for Hormone Levels for the Diagnosis of Cushing Syndrome (NCT00001453)

Eligibility criteria:
-  INCLUSION CRITERIA:

        Patients with the following characteristics may be included in the protocol:

        Age 18-75 years.

        Evidence of Cushing syndrome. Evidence to suggest overactivity of the
        hypothalamic-pituitary-adrenal axis, such as increased urinary excretion of glucocorticoids
        or lack of suppressibility with low doses of dexamethasone in conjunction with clinical
        features, will be sought prior to admission.

        EXCLUSION CRITERIA:

        Patients will be excluded from entry to the protocol if:

        A clear-cut pituitary tumor is present on T1-weighted conventional pituitary MR scan.

        There is any contraindication to catheterization. Patients with known reaction to contrast
        material will be excluded from this elective study if they have a strong history of
        previous contrast media reaction and cannot be studied safely by giving medical prophylaxis
        before the procedure.

        The patient is pregnant.

        Combined blood withdrawal during the six weeks preceding the study exceeds 450 ml, or if
        hematocrit at entry is less than 33%.

        Because of the increased risk of morbidity caused by contrast dyes in patients with a renal
        dysfunction, patients with a creatinine greater than 1.3 mg/dl will be excluded.

        Patients with a diastolic blood pressure persistently greater than 100 mm Hg (with or
        without medication) will be excluded from sampling procedures.

        They have had radiation exposure during the previous year that represents a significant
        additive risk in combination with the expected doses in this protocol. Patients and their
        doctors will be questioned about their exposure to radiation before they are accepted into
        the protocol.

        For the questionnaire only, patients who do not speak and read English will be excluded.
        This instrument has not been validated in non-English speakers.
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.
Subject must be at most 75 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