Updated Diagnostic Cortisol Values for Adrenal Insufficiency
ConditionAdrenal Insufficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cosyntropin stimulation test
Diagnostic testIn 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Healthy volunteersActive comparator 1 intervention
Group B: Patients with known adrenal insufficiencyActive comparator 1 intervention
Group C: Patients suspected to have adrenal insufficiencyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cortisol threshold with cosyntropin stimulation test
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.
Time frame
0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation timeSecondary outcomes
1
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. Results will be summarized by study arm,
Time frame
0 minutes (pre-cosyntropin administration) and 30 and 60 minutes post-cosyntropin administration; up to 2 hours participation timeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Montefiore Medical Center
Lead sponsor
Medical College of Wisconsin
Collaborator
Source ClinicalTrials.gov