Who is eligible for clinical trial NCT05149638?

Participants must meet the protocol's inclusion criteria for Adrenal Insufficiency. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05149638 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-02-18

Updated Diagnostic Cortisol Values for Adrenal Insufficiency (NCT05149638)

Re-assessment of Diagnostic Cortisol Values for Adrenal Insufficiency Using a Highly Specific Cortisol Assay

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Montefiore Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (21 items).

Location: Montefiore Medical Center — The Bronx, New York

Age range: 18 Years

🧪 Interventions in This Study

Cosyntropin stimulation test (DIAGNOSTIC_TEST)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Montefiore Medical Center — The Bronx, New York

📞 Contact the Study Coordinator

Phone: (718) 839-7322

Email: smabraham@montefiore.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Adrenal Insufficiency

Evaluation of Children With Endocrine and Metabolic-Related Conditions — Bethesda, Maryland

Explore by condition: All Adrenal Insufficiency clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗