Clinical trial: Dynamic Hormone Diagnostics in Endocrine Disease (NCT02934399)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy male and female subjects aged 18-68 years, non-smokers or regular smokers of
             greater than 6 cigarettes a day, BMI 16-29

          -  Male and female Cushing's syndrome aged 18-68 years with biochemically confirmed based
             on cortisol and ACTH measurements, dexamethasone suppression test and 1 of the
             following positive investigations (24 hour urine cortisol, salivary/serum cortisol
             profile). Visible tumour in the pituitary and/or one of the following positive tests
             pointing to pituitary source for ACTH overproduction (bilateral petrosal sinus
             sampling, corticotropin releasing hormone test, high dose dexamethasone suppression
             test) or adrenal tumour considered fit for surgery. No contraceptives for 6 weeks
             prior to sampling (females only). Patients on medical therapy e.g. metyrapone for
             Cushings to have a 2 week washout off treatment prior to sampling

          -  Male and female aged 18 -68 years with biochemically confirmed adrenal insufficiency
             based on basal cortisol and ACTH measurements and/or Synacthen test +/- adrenal
             antibodies, and on oral hydrocortisone or cortisone acetate glucocorticoid replacement
             therapy

          -  Female aged 18-68 years with biochemically confirmed salt-wasting or simple virilising
             CAH based on 17OHP, cortisol, androgen, renin and ACTH measurements; disease causing
             mutation in CYP21A2 and/or synacthen testing.

          -  Male and female subjects aged 18 -68 years with biochemical confirmation of PHA based
             on a valid pathological aldosterone/renin ratio and non-suppressible aldosterone
             levels on one of the currently used confirmatory tests (saline/oral fludrocortisone
             test). Unilateral only - diagnostic CT and/or adrenal vein sampling

          -  Male and female subjects aged 18-68 years with biochemically confirmed GHD (arginine
             growth hormone releasing hormone test, insulin tolerance test, known pituitary disease
             with confirmed pan hypopituitarism)

          -  Male and female aged 18-68 years with biochemically confirmed acromegaly (oral glucose
             tolerance test or GH day curve and diagnostic insulin growth factor 1 levels) with
             radiological evidence of a pituitary adenoma.

        Exclusion Criteria:

          -  Healthy controls undergoing or planning pregnancy or lactating women. Presence of any
             unstable pathological condition in past 3 months. On any regular prescribed
             medications (except contraception). Prior or current history of an endocrine disorder.
             Known allergy to Lignocaine, plasters. Current or past steroid therapies (oral,
             inhaled, parenteral or topical) or other interfering medication in last 3 months.
             Regular alcohol intake great then 26units of alcohol per week.Taking of any
             investigational drug within the past two months. Abuse of illicit drugs. Occasional
             smokers of cigarettes not able to abstain for sampling period or smoking less than 6
             cigarettes a day. Needle phobia. Interfering diet/over the counter herbal remedies in
             last 14 days.

          -  Cushing syndrome: Undergoing or planning pregnancy (females only). Known allergy to
             Lignocaine. Adrenal cancer (post-operative histology diagnosis),cyclic Cushings,
             squamous cell lung carcinoma, bronchial carcinoid and occult ectopic Cushings.
             Concurrent use of steroid therapy for any other medical condition (oral, inhaled,
             parenteral or topical)

          -  Adrenal insufficiency: Undergoing or planning pregnancy, known allergy to Lignocaine,
             use of other steroid medications other than their standard glucocorticoid and
             fludrocortisone replacement, other interfering medication or diet within 2 weeks of
             sampling.

          -  CAH: Males, females undergoing or planning pregnancy, known allergy to Lignocaine, use
             of other steroid medications other than their standard glucocorticoid and
             fludrocortisone replacement or other interfering medication or diet within 2 weeks of
             sampling

          -  Primary hyperaldosteronism: Undergoing or planning pregnancy (females only), known
             allergy to Lidocaine, known adrenal failure and/or on steroid therapy (oral, inhaled,
             parenteral or topical), concurrent use of interfering medication ( i.e. specific
             interfering antihypertensive medication) or diet within 2-4 weeks of ultradian
             sampling

          -  GHD: Undergoing or planning pregnancy (females only) or known allergy to Lignocaine

          -  Acromegaly: Undergoing or planning pregnancy (females only), known allergy to
             Lignocaine treatment with somatostatin analogues and other interfering medication
             (e.g. oestrogens)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 68 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