Updated Diagnostic Cortisol Values for Adrenal Insufficiency

NCT05149638 | Recruiting

• 1 other identifier: 2021-13420
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time

Secondary Outcomes (1)

• Cortisol threshold with basal, morning level

  0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time

Study Arms (3)

Healthy volunteers

ACTIVE COMPARATOR

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

Patients with known adrenal insufficiency

ACTIVE COMPARATOR

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

Patients suspected to have adrenal insufficiency

ACTIVE COMPARATOR

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

Interventions

Cosyntropin stimulation test DIAGNOSTIC_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.

Healthy volunteers; Patients suspected to have adrenal insufficiency; Patients with known adrenal insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Male and female outpatients 18 years or older without prior diagnosis of primary or central 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
• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Medical College of Wisconsin: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Smita B Abraham, MD

  Albert Einstein - Montefiore Medical Center, Bronx, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Smita B Abraham, MD

CONTACT

718-839-7322; smabraham@montefiore.org

Noah Bloomgarden, MD

CONTACT

nbloomga@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, cross-sectional study design consisting of one study visit during which the study participant will undergo cosyntropin stimulation test. The three groups in the study are healthy volunteers (HV; n = 30), patients with known primary or central adrenal insufficiency (n = 30), and patients suspected to have primary or central adrenal insufficiency (n = 30).

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: February 3, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)