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Updated Diagnostic Cortisol Values for Adrenal Insufficiency

RecruitingNAAges 18 Years - anyAllMontefiore Medical Center
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to determine the cortisol levels that most accurately diagnose a patient with adrenal insufficiency, a condition in which cortisol levels are too low for daily living.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria for healthy volunteers: \- Male and female outpatients 18 years or older without prior diagnosis of primary or central adrenal insufficiency Inclusion Criteria for patients with known adrenal insufficiency: \- Males and females 18 years or older with established diagnosis of primary or central adrenal insufficiency as previously documented in the electronic medical record by a failed CST (peak cortisol level \< 18 ฮผg/dL) or morning serum cortisol \< 3 mcg/dL with an appropriate clinical circumstance (e.g., Sheehan's syndrome, pituitary surgery and/or irradiation, bilateral adrenalectomy, etc.) that strongly supports a true diagnosis of primary or central adrenal insufficiency, and current use of physiologic, replacement dose glucocorticoids. Inpatients with non-critical illness and outpatients are eligible Inclusion Criteria for patients with suspected adrenal insufficiency: \- Males and females 18 years or older with suspected diagnosis of primary or central adrenal insufficiency by any cause based on clinical evaluation by a study team member. Inpatients with non-critical illness and outpatients are eligible Exclusion Criteria for all groups: * Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73m2 and/or diagnosis of nephrotic syndrome * Pregnancy or nursing mothers * Use of estrogen preparations * Uncontrolled major depressive disorder or psychiatric diseases, severe malnutrition, eating disorders, chronic fatigue syndrome (disorders that alter hypothalamic-pituitary-adrenal (HPA) axis function) * Use of any medications that induce hepatic cytochrome P-450 enzymes, e.g., barbiturates, phenytoin, rifampin, aminoglutethimide and mitotane * Active medical treatment of Cushing's syndrome (status-post surgical treatment is acceptable) * Uncontrolled hypo- or hyperthyroidism * Use of biotin within the past 72 hours * Regular alcohol and/or cannabis use * History of bilateral adrenalectomy * Treatment for validated primary adrenal insufficiency for greater than 6 months * Be assessed by the investigators as unsuitable for participation in this study for any reason Additional Exclusion Criteria for healthy volunteers only: * Regular use of any oral glucocorticoid (e.g. hydrocortisone, prednisone, dexamethasone) within 6 weeks of the screening visit * Use of oral or nasal steroid (glucocorticoid) inhalers in the past 2 weeks * Regular use of any steroid creams, gels, ointments, or lotions * Use of steroid (glucocorticoid) injections in the past 6 months (healthy volunteers) * Regular use of opioids * Regular use of suboxone * Regular use of megestrol acetate
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What it tests

  • Cosyntropin stimulation test
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Where

1 site
Montefiore Medical Center
The Bronx, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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