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Cosyntropin Test for Adrenal Fatigue

N/A
Recruiting
Led By Smita B Abraham, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 cosyntropin stimulation test (peak cortisol level < 18 μg/dL) and current use of physiologic, replacement dose glucocorticoids.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study Summary

This trial is testing what the best level of cortisol is to diagnose adrenal insufficiency, a condition where people don't have enough cortisol.

Who is the study for?
This trial is for adults over 18 who may have adrenal insufficiency, which means their bodies don't make enough cortisol. It's open to those with a suspected or confirmed diagnosis but not currently on certain steroids, opioids, or other excluded medications. Pregnant women and individuals with specific health conditions like severe liver or kidney issues can't participate.Check my eligibility
What is being tested?
The study aims to find the most accurate cortisol levels for diagnosing adrenal insufficiency using the cosyntropin stimulation test. This will help determine if someone's cortisol levels are too low for daily activities.See study design
What are the potential side effects?
While the document doesn’t specify side effects of the cosyntropin stimulation test, it generally has minimal risks. Possible side effects might include swelling and pain at the injection site; allergic reactions are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and have never been diagnosed with adrenal insufficiency.
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I am 18 or older with adrenal insufficiency confirmed by a test and I'm on glucocorticoids.
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I am 18 or older and have never been diagnosed with adrenal insufficiency.
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I have adrenal insufficiency, confirmed by a test, and am on glucocorticoids.
Select...
I am 18 or older and may have adrenal insufficiency as evaluated by a study team.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cortisol threshold with cosyntropin stimulation test
Secondary outcome measures
Cortisol threshold with basal, morning level

Trial Design

3Treatment groups
Active Control
Group I: Patients with known adrenal insufficiencyActive Control1 Intervention
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.
Group II: Patients suspected to have adrenal insufficiencyActive Control1 Intervention
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.
Group III: Healthy volunteersActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
440 Previous Clinical Trials
581,521 Total Patients Enrolled
Smita B Abraham, MDPrincipal InvestigatorAlbert Einstein - Montefiore Medical Center, Bronx, New York

Media Library

Patients with known adrenal insufficiency Clinical Trial Eligibility Overview. Trial Name: NCT05149638 — N/A
Adrenal Fatigue Research Study Groups: Patients with known adrenal insufficiency, Patients suspected to have adrenal insufficiency, Healthy volunteers
Adrenal Fatigue Clinical Trial 2023: Patients with known adrenal insufficiency Highlights & Side Effects. Trial Name: NCT05149638 — N/A
Patients with known adrenal insufficiency 2023 Treatment Timeline for Medical Study. Trial Name: NCT05149638 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are enrolled in this investigation?

"Affirmative. According to clinicaltrials.gov, this investigation is presently actively enrolling patients, having been posted on February 3rd 2022 and amended most recently on July 2nd 2022. A total of 90 subjects must be recruited from a single study site."

Answered by AI

Is recruitment for this experiment still ongoing?

"The trial's entry on clinicaltrials.gov affirms that the study is currently open to enrollment, which began in February 3rd 2022 and was recently amended on February 7th 2022."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Montefiore Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~40 spots leftby Dec 2025