Clinical trial: Long Term Post Operative Follow-Up of Cushing Syndrome (NCT00029952)

Eligibility criteria:
INCLUSION CRITERIA:

        Patients with Cushing syndrome documented at the NIH will be recruited into this protocol
        prior to surgery intended to cure Cushing syndrome selectively. Thus, patients undergoing
        transsphenoidal exploration for resection of an adenoma, or unilateral adrenalectomy for an
        adenoma, or resection of a tumor producing ACTH ectopically will be candidates for this
        study. We will also recruit as many of the 500 patients treated since 1983 as possible, so
        as to have a group of "late follow-up" patients. These individuals will participate
        primarily by questionnaire.

        Hematocrit about 30%. A CBC will be obtained prior to entering the study. Patients with
        hematocrit above 30% will be accepted into the study; iron replacement will be given to
        those patients with low TIBC.

        Ages 18 - 85. Children less than 18 are being studied under other protocols and the
        questionnaire has not been validated for younger individuals.

        For the questionnaire portion of the protocol there is an additional inclusion criterion:

        Patients must be able to read and write in English.

        EXCLUSION CRITERIA:

        There are no formal exclusion criteria, if the patient meets the inclusion criteria above.
        All ethnic groups and both genders will be recruited. However, patients may be withdrawn
        from the study by the PI if they are unable to meet study requirments, such as mailing
        questionnaires.
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? Contradiction