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Updated Diagnostic Cortisol Values for Adrenal Insufficiency

This study aims to improve how adrenal insufficiency (a condition where your body doesn't make enough cortisol) is diagnosed. Researchers are using a routine medical test called the cosyntropin stimulation test. In this test, you'll receive an intramuscular injection of Cosyntropin, and your cortisol levels will be measured before and after. The goal is to find the most accurate cortisol levels that indicate adrenal insufficiency. The study is looking for both healthy volunteers and people already diagnosed with adrenal insufficiency, aged 18 and older. This research will help doctors better identify who has adrenal insufficiency.

Study design
This is an interventional study with a planned enrollment of 90 participants. It is not specified if it is randomized or blinded.
What's involved
You would participate for about two hours, during which you would receive an intramuscular injection of Cosyntropin and have your cortisol levels measured at different times.
Compensation
Not stated in the trial record.
Follow-up
Cortisol levels are measured up to 2 hours post-cosyntropin administration, which is the extent of participation time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05149638

Updated Diagnostic Cortisol Values for Adrenal Insufficiency

Recruiting
NAAges 18+InterventionalDiagnostic
Montefiore Medical Center
~90 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Cosyntropin stimulation test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cortisol threshold with cosyntropin stimulation test
Measured over 0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time

Conditions

Adrenal Insufficiency

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NCT05149638

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Montefiore Medical Center

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Smita B Abraham, MD · PRINCIPAL_INVESTIGATOR · Albert Einstein - Montefiore Medical Center, Bronx, New York

Who to contact

Smita B Abraham, MD
[email protected]
718-839-7322
Email the study team

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Eligibility criteria

Exclusion

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
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

What this trial measures

  • Cortisol threshold with cosyntropin stimulation test0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time

    To accurately re-define the cortisol threshold to diagnose adrenal insufficiency (AI) with cosyntropin stimulation test (CST) using the Alinity, monoclonal antibody, cortisol assay. The cortisol threshold for the diagnosis of AI using the Alinity assay is 18 ug/dL. Results from the CST assay will be summarized by study arm/group to determine a new cut-point for patients with suspected primary or central AI.