Actively Recruiting
Updated Diagnostic Cortisol Values for Adrenal Insufficiency
Led by Montefiore Medical Center · Updated on 2026-02-19
90
Participants Needed
1
Research Sites
303 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
M
Medical College of Wisconsin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Updated Diagnostic Cortisol Values for Adrenal Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female outpatients 18 years or older without prior diagnosis of adrenal insufficiency
- Males and females 18 years or older with established diagnosis of primary or central adrenal insufficiency documented by failed CST or low morning cortisol with supporting clinical circumstances and current physiologic glucocorticoid use
- Males and females 18 years or older with suspected primary or central adrenal insufficiency based on clinical evaluation
You will not qualify if you...
- Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin levels
- Kidney impairment with estimated Glomerular Filtration Rate below 60 mL/min/1.73m2 or nephrotic syndrome
- Pregnancy or nursing mothers
- Use of estrogen preparations
- Uncontrolled major depressive disorder, psychiatric diseases, severe malnutrition, eating disorders, or chronic fatigue syndrome
- Use of medications inducing hepatic cytochrome P-450 enzymes such as barbiturates, phenytoin, rifampin, aminoglutethimide, or mitotane
- Active treatment for Cushing's syndrome (post-surgical treatment allowed)
- Uncontrolled hypo- or hyperthyroidism
- Use of biotin within past 72 hours
- Regular alcohol and/or cannabis use
- History of bilateral adrenalectomy
- Treatment for primary adrenal insufficiency for more than 6 months
- Investigator assessment of unsuitability for participation
- For healthy volunteers: regular use of oral glucocorticoids within 6 weeks, steroid inhalers in past 2 weeks, steroid creams or ointments, steroid injections in past 6 months, regular opioid use, regular suboxone use, or regular megestrol acetate use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
S
Smita B Abraham, MD
CONTACT
N
Noah Bloomgarden, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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