Updated Diagnostic Cortisol Values for Adrenal Insufficiency

Adrenal Insufficiency Clinical Trial

Official title:

Re-assessment of Diagnostic Cortisol Values for Adrenal Insufficiency Using a Highly Specific Cortisol Assay

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05149638
• Other study ID #: 2021-13420
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: Montefiore Medical Center
• Contact: Smita B Abraham, MD
• Phone: 718-839-7322
• Email: smabraham[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol threshold with cosyntropin stimulation test	To accurately re-define the cortisol threshold to diagnose adrenal insufficiency with cosyntropin stimulation test using the Alinity, monoclonal antibody, cortisol assay.	1 day
Secondary	Cortisol threshold with basal, morning level	To determine a basal, morning, cortisol level above which adrenal insufficiency can be ruled out using the Alinity cortisol assay.	1 day