Determining accurate cortisol levels for diagnosing adrenal insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish updated cortisol thresholds for diagnosing adrenal insufficiency using a cosyntropin (ACTH) stimulation test. Participants will receive an intramuscular injection of cosyntropin, and their cortisol levels will be measured before and after the injection. The study will compare the diagnostic thresholds of cortisol levels using two different assays, the Abbott Alinity and Roche 2 assays. The overall goal is to improve the accuracy of diagnosing adrenal insufficiency, which is critical for effective patient management.

Why it matters

Who can join: the full rules

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 μg/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

Where it's running

• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Smita B Abraham, MD — Albert Einstein - Montefiore Medical Center, Bronx, New York
• Study coordinator: Smita B Abraham, MD
• Email: smabraham@montefiore.org
• Phone: 718-839-7322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.