Determining accurate cortisol levels for diagnosing adrenal insufficiency
Re-assessment of Diagnostic Cortisol Values for Adrenal Insufficiency Using a Highly Specific Cortisol Assay
This study is testing new ways to measure cortisol levels in people to see if it helps doctors better diagnose adrenal insufficiency.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05149638 on ClinicalTrials.gov |
What this trial studies
This study aims to establish updated cortisol thresholds for diagnosing adrenal insufficiency using a cosyntropin (ACTH) stimulation test. Participants will receive an intramuscular injection of cosyntropin, and their cortisol levels will be measured before and after the injection. The study will compare the diagnostic thresholds of cortisol levels using two different assays, the Abbott Alinity and Roche 2 assays. The overall goal is to improve the accuracy of diagnosing adrenal insufficiency, which is critical for effective patient management.
Who should consider this trial
Good fit: Ideal candidates include adults 18 years or older with known or suspected adrenal insufficiency or healthy volunteers without prior diagnosis of adrenal insufficiency.
Not a fit: Patients who do not have adrenal insufficiency or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of adrenal insufficiency, allowing for better treatment and management of affected patients.
How similar studies have performed: Other studies have shown success in using cosyntropin stimulation tests for diagnosing adrenal insufficiency, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion 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 CST (peak cortisol level \< 18 μg/dL) or morning serum cortisol \< 3 mcg/dL with an appropriate clinical circumstance (e.g., Sheehan's syndrome, pituitary surgery and/or irradiation, bilateral adrenalectomy, etc.) that strongly supports a true diagnosis of primary or central adrenal insufficiency, and current use of physiologic, replacement dose glucocorticoids. Inpatients with non-critical illness and outpatients are eligible 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. Inpatients with non-critical illness and outpatients are eligible Exclusion Criteria for all groups: * Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73m2 and/or diagnosis of nephrotic syndrome * Pregnancy or nursing mothers * Use of estrogen preparations * Uncontrolled major depressive disorder or psychiatric diseases, severe malnutrition, eating disorders, chronic fatigue syndrome (disorders that alter hypothalamic-pituitary-adrenal (HPA) axis function) * Use of any medications that induce hepatic cytochrome P-450 enzymes, e.g., barbiturates, phenytoin, rifampin, aminoglutethimide and mitotane * Active medical treatment of Cushing's syndrome (status-post surgical treatment is acceptable) * Uncontrolled hypo- or hyperthyroidism * Use of biotin within the past 72 hours * Regular alcohol and/or cannabis use * History of bilateral adrenalectomy * Treatment for validated primary adrenal insufficiency for greater than 6 months * Be assessed by the investigators as unsuitable for participation in this study for any reason Additional Exclusion Criteria for healthy volunteers only: * Regular use of any oral glucocorticoid (e.g. hydrocortisone, prednisone, dexamethasone) within 6 weeks of the screening visit * Use of oral or nasal steroid (glucocorticoid) inhalers in the past 2 weeks * Regular use of any steroid creams, gels, ointments, or lotions * Use of steroid (glucocorticoid) injections in the past 6 months (healthy volunteers) * Regular use of opioids * Regular use of suboxone * Regular use of megestrol acetate
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Smita B Abraham, MD — Albert Einstein - Montefiore Medical Center, Bronx, New York
- Study coordinator: Smita B Abraham, MD
- Email: smabraham@montefiore.org
- Phone: 718-839-7322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.