Updated Diagnostic Cortisol Values for Adrenal Insufficiency

Launched by MONTEFIORE MEDICAL CENTER · Nov 24, 2021

Keywords

ClinConnect Summary

This clinical trial is looking to find the best cortisol levels to diagnose adrenal insufficiency, a condition where the body does not produce enough cortisol, which is important for everyday health. The researchers aim to identify the most accurate values that can help doctors diagnose this condition effectively. The trial is currently recruiting participants, including healthy volunteers and individuals who already have or are suspected of having adrenal insufficiency.

To be eligible for the trial, participants need to be at least 18 years old. Healthy volunteers should not have been diagnosed with adrenal insufficiency before. Patients with known adrenal insufficiency need to have a documented diagnosis and be receiving proper treatment. Those suspected of having the condition can also join based on their doctor's evaluation. Participants can expect to undergo tests that measure cortisol levels and help improve understanding of this important hormone. It's worth noting that certain medical conditions and medications could prevent someone from participating, so it's important to discuss any concerns with the study team.

Gender

ALL

Eligibility 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:
• • 1. Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations
• • 2. Renal impairment with eGFR \< 60 mL/min/1.73m2 and/or diagnosis of nephrotic syndrome
• • 3. Pregnancy or nursing mothers
• • 4. Use of estrogen preparations
• • 5. Major depressive disorder, severe malnutrition, anorexia, chronic fatigue syndrome (disorders that alter HPA axis function)
• • 6. Use of any medications that induce hepatic cytochrome P-450 enzymes, e.g., barbiturates, phenytoin, rifampin, amino-glutethimide and mitotane
• • 7. Active medical treatment of Cushing's syndrome (status-post surgical treatment is acceptable)
• • 8. Uncontrolled hypo- or hyperthyroidism
• • 9. Use of biotin within the past 72 hours
• • 10. Regular alcohol and/or cannabis use
• • 11. Be assessed by the investigators as unsuitable for participation in this study for any reason.
• Additional Exclusion Criteria for healthy volunteers only:
• • 12. Regular use of any oral glucocorticoid (e.g. hydrocortisone, prednisone, dexamethasone) within 6 weeks of the screening visit
• • 13. Use of oral or nasal steroid (glucocorticoid) inhalers in the past 2 weeks
• • 14. Regular use of any steroid creams, gels, ointments, or lotions
• • 15. Use of steroid (glucocorticoid) injections in the past 6 months
• • 16. Regular use of opioids
• • 17. Regular use of suboxone
• • 18. Regular use of megestrol acetate