An interventional study of Cosyntropin stimulation test in Adrenal Insufficiency, sponsored by Montefiore Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Diagnostic
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.
In this study, a cosyntropin (ACTH) stimulation test will be conducted by administering intramuscular cosyntropin into a subject's arm and measuring cortisol levels before and after injection. Cosyntropin tests are routine medical tests that are done in doctors' offices to diagnose adrenal insufficiency. Cosyntropin is a synthetic version of a hormone, called ACTH, that is secreted by our bodies to help produce cortisol. Participation in this research will last about two hours.
Aim # 1:
The primary aim is to accurately re-define the cortisol threshold to diagnose adrenal insufficiency with cosyntropin stimulation test using the Alinity, monoclonal antibody, cortisol assay.
Aim # 2:
The secondary aims are to determine a basal, morning, cortisol level above which adrenal insufficiency can be ruled out using the Alinity cortisol assay and to compare diagnostic cortisol thresholds within the cosyntropin stimulation test between the Abbott Alinity assay and the Roche 2 assay.
132 studies on the registry are indexed under Adrenal Insufficiency; 26 are open to participants now.
This study's planned enrollment of 90 is above the median of 37 across 70 interventional studies indexed under Adrenal Insufficiency.
Browse Adrenal Insufficiency studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
- 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:
Additional Exclusion Criteria for healthy volunteers only:
Healthy volunteers are those 18 years or older without prior diagnosis of adrenal insufficiency. Study participation by healthy volunteers helps us understand what cortisol levels should be in a healthy population. This information also helps us figure out what levels might be in people with adrenal insufficiency.
Diagnostic Test: Cosyntropin stimulation test
This group consists of patients 18 years or older with an established diagnosis of adrenal insufficiency. Study participation by patients with adrenal insufficiency helps us understand what cortisol levels should be, in the new assays, among those with adrenal insufficiency.
Diagnostic Test: Cosyntropin stimulation test
This groups consists of patients 18 years or older who are suspected to have adrenal insufficiency. Study participation by this group will help us understand if the cortisol values we get from the new assay accurately diagnose adrenal insufficiency.
Diagnostic Test: Cosyntropin stimulation test
In this test, Cosyntropin is administered as an intramuscular injection into the arm. Cortisol levels are measured before and after injection. Cosyntropin tests are routine medical tests that are done in doctors' offices to diagnose adrenal insufficiency. Cosyntropin is a synthetic version of a hormone, called ACTH, that is secreted by our bodies to help produce cortisol.
Cortisol threshold with cosyntropin stimulation test
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.
Time frame: 0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time
Cortisol threshold with basal, morning level
To determine a basal, morning, cortisol level above which adrenal insufficiency can be ruled out using the Alinity cortisol assay. Results will be summarized by study arm,
Time frame: 0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time
Plan to share: Undecided
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