Updated Diagnostic Cortisol Values for Adrenal Insufficiency

What Was Tested

This registered not phased trial tested Cosyntropin.

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.

It had three arms (groups): Healthy volunteers (active comparator), Patients with known adrenal insufficiency (active comparator) and Patients suspected to have adrenal insufficiency (active comparator).

Healthy volunteers are those 18 years or older without prior diagnosis of adrenal insufficiency. Study participation by healthy volunteers helps them understand what cortisol levels should be in a healthy population. This information also helps them figure out what levels might be in people with adrenal insufficiency.

This group consists of patients 18 years or older with an established diagnosis of adrenal insufficiency. Study participation by patients with adrenal insufficiency helps them understand what cortisol levels should be, in the new assays, among those with adrenal insufficiency.

This groups consists of patients 18 years or older who are suspected to have adrenal insufficiency. Study participation by this group will help them understand if the cortisol values the researchers get from the new assay accurately diagnose adrenal insufficiency.

The registry classes the interventions as diagnostic test.

More on the Plan

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 is a synthetic version of a hormone, called ACTH, that is secreted by their 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.

Who Took Part

90 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

The full record lists 0 inclusion and 20 exclusion criteria; among the exclusions: moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations; pregnancy or nursing mothers; use of estrogen preparations.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Cosyntropin study did not mask who received what.

It started in 2022-02-03 with completion listed for 2027-12-01.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Cortisol threshold with cosyntropin stimulation test.

It also tracked 1 secondary outcome, for example Cortisol threshold with basal, morning level.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cosyntropin in 90 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cosyntropin compound page, all human trials.