Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05149638

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

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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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Updated Diagnostic Cortisol Values for Adrenal Insufficiency | DecenTrialz