Updated Diagnostic Cortisol Values for Adrenal Insufficiency
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
In this study, a cosyntropin (ACTH) stimulation test will be conducted by administering intramuscular cosyntropin into a subject's arm and measuring cortisol levels before and after injection. Cosyntropin tests are routine medical tests that are done in doctors' offices to diagnose adrenal insufficiency. Cosyntropin is a synthetic version of a hormone, called ACTH, that is secreted by our bodies to help produce cortisol. Participation in this research will last about two hours.
Aim # 1:
The primary aim is to accurately re-define the cortisol threshold to diagnose adrenal insufficiency with cosyntropin stimulation test using the Alinity, monoclonal antibody, cortisol assay.
Aim # 2:
The secondary aims are to determine a basal, morning, cortisol level above which adrenal insufficiency can be ruled out using the Alinity cortisol assay and to compare diagnostic cortisol thresholds within the cosyntropin stimulation test between the Abbott Alinity assay and the Roche 2 assay.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Healthy volunteers 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. |
Diagnostic Test: Cosyntropin stimulation test
In this test, Cosyntropin is administered as an intramuscular injection into the arm. Cortisol levels are measured before and after injection. Cosyntropin tests are routine medical tests that are done in doctors' offices to diagnose adrenal insufficiency. Cosyntropin is a synthetic version of a hormone, called ACTH, that is secreted by our bodies to help produce cortisol.
|
| Active Comparator: Patients with known adrenal insufficiency 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. |
Diagnostic Test: Cosyntropin stimulation test
In this test, Cosyntropin is administered as an intramuscular injection into the arm. Cortisol levels are measured before and after injection. Cosyntropin tests are routine medical tests that are done in doctors' offices to diagnose adrenal insufficiency. Cosyntropin is a synthetic version of a hormone, called ACTH, that is secreted by our bodies to help produce cortisol.
|
| Active Comparator: Patients suspected to have adrenal insufficiency 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. |
Diagnostic Test: Cosyntropin stimulation test
In this test, Cosyntropin is administered as an intramuscular injection into the arm. Cortisol levels are measured before and after injection. Cosyntropin tests are routine medical tests that are done in doctors' offices to diagnose adrenal insufficiency. Cosyntropin is a synthetic version of a hormone, called ACTH, that is secreted by our bodies to help produce cortisol.
|
Outcome Measures
Primary Outcome Measures
- Cortisol threshold with cosyntropin stimulation test [2 years]
To accurately re-define the cortisol threshold to diagnose adrenal insufficiency with cosyntropin stimulation test using the Alinity, monoclonal antibody, cortisol assay.
Secondary Outcome Measures
- Cortisol threshold with basal, morning level [2 years]
To determine a basal, morning, cortisol level above which adrenal insufficiency can be ruled out using the Alinity cortisol assay.
Eligibility Criteria
Criteria
Inclusion Criteria 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 cosyntropin stimulation test (peak cortisol level < 18 μg/dL) and current use of physiologic, replacement dose glucocorticoids.
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.
Exclusion Criteria for all groups:
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Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations
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Renal impairment with eGFR < 60 mL/min/1.73m2 and/or diagnosis of nephrotic syndrome
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Pregnancy or nursing mothers
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Use of estrogen preparations
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Major depressive disorder, severe malnutrition, anorexia, chronic fatigue syndrome (disorders that alter HPA axis function)
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Use of any medications that induce hepatic cytochrome P-450 enzymes, e.g., barbiturates, phenytoin, rifampin, amino-glutethimide and mitotane
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Active medical treatment of Cushing's syndrome (status-post surgical treatment is acceptable)
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Use of oral or nasal steroid inhalers in the past two weeks (healthy volunteers and patients with known adrenal insufficiency only)*
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Regular use of hydrocortisone cream.
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Use of steroid injections in the past 6 months (healthy volunteers and patients with known adrenal insufficiency only) *
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Regular use of alcohol (healthy volunteers and patients with known adrenal insufficiency only)*
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Regular use of opioids (healthy volunteers and patients with known adrenal insufficiency only)*
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Regular use of suboxone (healthy volunteers and patients with known adrenal insufficiency only)*
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Regular use of megestrol acetate (healthy volunteers and patients with known adrenal insufficiency only)*
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Use of biotin in the past 72 hours
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Uncontrolled hypo- or hyperthyroidism
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
Sponsors and Collaborators
- Montefiore Medical Center
Investigators
- Principal Investigator: Smita B Abraham, MD, Albert Einstein - Montefiore Medical Center, Bronx, New York
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-13420