Updated Diagnostic Cortisol Values for Adrenal Insufficiency
NCT ID: NCT05149638
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2022-02-03
2027-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy volunteers
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.
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.
Patients with known adrenal insufficiency
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.
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.
Patients suspected to have adrenal insufficiency
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
\- 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
\- 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
* Renal impairment with 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 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
* 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
18 Years
ALL
Yes
Sponsors
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Medical College of Wisconsin
OTHER
Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Smita B Abraham, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein - Montefiore Medical Center, Bronx, New York
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24.
Giordano R, Marzotti S, Balbo M, Romagnoli S, Marinazzo E, Berardelli R, Migliaretti G, Benso A, Falorni A, Ghigo E, Arvat E. Metabolic and cardiovascular profile in patients with Addison's disease under conventional glucocorticoid replacement. J Endocrinol Invest. 2009 Dec;32(11):917-23. doi: 10.1007/BF03345773. Epub 2009 Jul 20.
Oelkers W. Adrenal insufficiency. N Engl J Med. 1996 Oct 17;335(16):1206-12. doi: 10.1056/NEJM199610173351607. No abstract available.
Dorin RI, Qiao Z, Qualls CR, Urban FK 3rd. Estimation of maximal cortisol secretion rate in healthy humans. J Clin Endocrinol Metab. 2012 Apr;97(4):1285-93. doi: 10.1210/jc.2011-2227. Epub 2012 Feb 15.
Reimondo G, Bovio S, Allasino B, Terzolo M, Angeli A. Secondary hypoadrenalism. Pituitary. 2008;11(2):147-54. doi: 10.1007/s11102-008-0108-4.
Bornstein SR, Allolio B, Arlt W, Barthel A, Don-Wauchope A, Hammer GD, Husebye ES, Merke DP, Murad MH, Stratakis CA, Torpy DJ. Diagnosis and Treatment of Primary Adrenal Insufficiency: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 Feb;101(2):364-89. doi: 10.1210/jc.2015-1710. Epub 2016 Jan 13.
Raverot V, Richet C, Morel Y, Raverot G, Borson-Chazot F. Establishment of revised diagnostic cut-offs for adrenal laboratory investigation using the new Roche Diagnostics Elecsys(R) Cortisol II assay. Ann Endocrinol (Paris). 2016 Oct;77(5):620-622. doi: 10.1016/j.ando.2016.05.002. Epub 2016 Jul 19. No abstract available.
Vogeser M, Kratzsch J, Ju Bae Y, Bruegel M, Ceglarek U, Fiers T, Gaudl A, Kurka H, Milczynski C, Prat Knoll C, Suhr AC, Teupser D, Zahn I, Ostlund RE. Multicenter performance evaluation of a second generation cortisol assay. Clin Chem Lab Med. 2017 May 1;55(6):826-835. doi: 10.1515/cclm-2016-0400.
Kline GA, Buse J, Krause RD. Clinical implications for biochemical diagnostic thresholds of adrenal sufficiency using a highly specific cortisol immunoassay. Clin Biochem. 2017 Jun;50(9):475-480. doi: 10.1016/j.clinbiochem.2017.02.008. Epub 2017 Feb 10.
Javorsky BR, Raff H, Carroll TB, Algeciras-Schimnich A, Singh RJ, Colon-Franco JM, Findling JW. New Cutoffs for the Biochemical Diagnosis of Adrenal Insufficiency after ACTH Stimulation using Specific Cortisol Assays. J Endocr Soc. 2021 Feb 18;5(4):bvab022. doi: 10.1210/jendso/bvab022. eCollection 2021 Apr 1.
Rosner W, Vesper H. Preface. CDC workshop report improving steroid hormone measurements in patient care and research translation. Steroids. 2008 Dec 12;73(13):1285. doi: 10.1016/j.steroids.2008.08.001. Epub 2008 Aug 5. No abstract available.
Ueland GA, Methlie P, Oksnes M, Thordarson HB, Sagen J, Kellmann R, Mellgren G, Raeder M, Dahlqvist P, Dahl SR, Thorsby PM, Lovas K, Husebye ES. The Short Cosyntropin Test Revisited: New Normal Reference Range Using LC-MS/MS. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1696-1703. doi: 10.1210/jc.2017-02602.
Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982 Apr;143(1):29-36. doi: 10.1148/radiology.143.1.7063747.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
Other Identifiers
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2021-13420
Identifier Type: -
Identifier Source: org_study_id
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