Adrenal Insufficiency
Conditions
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.
Interventions
DIAGNOSTIC_TESTCosyntropin 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.
Sponsors
Montefiore Medical Center
Medical College of Wisconsin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol threshold with cosyntropin stimulation test | 0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time | To accurately re-define the cortisol threshold to diagnose adrenal insufficiency (AI) with cosyntropin stimulation test (CST) using the Alinity, monoclonal antibody, cortisol assay. The cortisol threshold for the diagnosis of AI using the Alinity assay is 18 ug/dL. Results from the CST assay will be summarized by study arm/group to determine a new cut-point for patients with suspected primary or central AI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol threshold with basal, morning level | 0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation time | To determine a basal, morning, cortisol level above which adrenal insufficiency can be ruled out using the Alinity cortisol assay. Results will be summarized by study arm, |
Countries
United States
Contacts
CONTACTNoah Bloomgarden, MD
CONTACTSmita B Abraham, MD
PRINCIPAL_INVESTIGATORSmita B Abraham, MD
Albert Einstein - Montefiore Medical Center, Bronx, New York
Outcome results
None listed