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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.

Must not have

Regular use of hydrocortisone cream

Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use hydrocortisone cream.

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My liver is not working well, or I have abnormal protein levels in my blood.

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I regularly use opioids for pain management.

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I am not taking medications like barbiturates or rifampin that affect liver enzymes.

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My kidney function is reduced, with an eGFR below 60.

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I am currently using estrogen preparations.

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My thyroid condition is not under control.

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I am currently being treated for Cushing's syndrome or have had surgery for it.

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I regularly take megestrol acetate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cortisol threshold with cosyntropin stimulation test

Secondary study objectives

Cortisol threshold with basal, morning level

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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: 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.

Group III: 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.

0 / 13Eligibility criteria met