Clinical trial NCT05149638: Updated Diagnostic Cortisol Values for Adrenal Insufficiency
Official title: Re-assessment of Diagnostic Cortisol Values for Adrenal Insufficiency Using a Highly Specific Cortisol Assay
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adrenal Insufficiency
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2021-12-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, cross-sectional study design consisting of one study visit during which the study participant will undergo cosyntropin stimulation test. The three groups in the study are healthy volunteers (HV; n = 30), patients with known primary or central adrenal insufficiency (n = 30), and patients suspected to have primary or central adrenal insufficiency (n = 30).
Primary purpose: DIAGNOSTIC

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.

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.

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

Primary outcomes:
measure: Cortisol threshold with cosyntropin stimulation test
timeFrame: 0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time
Secondary outcomes:
measure: Cortisol threshold with basal, morning level
timeFrame: 0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein - Montefiore Medical Center, Bronx, New York
name: Smita B Abraham, MD
role: PRINCIPAL_INVESTIGATOR
References: