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Updated Diagnostic Cortisol Values for Adrenal Insufficiency

Primary Purpose

Adrenal Insufficiency

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cosyntropin stimulation test

About this trial

This is an interventional diagnostic trial for Adrenal Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 cosyntropin stimulation test (peak cortisol level < 18 μg/dL) and current use of physiologic, replacement dose glucocorticoids.

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.

Exclusion Criteria for all groups:

Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations
Renal impairment with eGFR < 60 mL/min/1.73m2 and/or diagnosis of nephrotic syndrome
Pregnancy or nursing mothers
Use of estrogen preparations
Major depressive disorder, severe malnutrition, anorexia, chronic fatigue syndrome (disorders that alter HPA axis function)
Use of any medications that induce hepatic cytochrome P-450 enzymes, e.g., barbiturates, phenytoin, rifampin, amino-glutethimide and mitotane
Active medical treatment of Cushing's syndrome (status-post surgical treatment is acceptable)
Use of oral or nasal steroid inhalers in the past two weeks (healthy volunteers and patients with known adrenal insufficiency only)*
Regular use of hydrocortisone cream.
Use of steroid injections in the past 6 months (healthy volunteers and patients with known adrenal insufficiency only) *
Regular use of alcohol (healthy volunteers and patients with known adrenal insufficiency only)*
Regular use of opioids (healthy volunteers and patients with known adrenal insufficiency only)*
Regular use of suboxone (healthy volunteers and patients with known adrenal insufficiency only)*
Regular use of megestrol acetate (healthy volunteers and patients with known adrenal insufficiency only)*
Use of biotin in the past 72 hours
Uncontrolled hypo- or hyperthyroidism

Sites / Locations

Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Healthy volunteers

Patients with known adrenal insufficiency

Patients suspected to have adrenal insufficiency

Arm Description

Healthy volunteers are those 18 years or older without prior diagnosis of adrenal insufficiency. Study participation by healthy volunteers helps us understand what cortisol levels should be in a healthy population. This information also helps us 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 us 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 us understand if the cortisol values we get from the new assay accurately diagnose adrenal insufficiency.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05149638

First Posted

November 24, 2021

Last Updated

January 23, 2023

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05149638

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 3, 2022 (Actual)

Primary Completion Date

December 1, 2025 (Anticipated)

Study Completion Date

December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adrenal Insufficiency

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy volunteers

Arm Type

Active Comparator

Arm Description

Arm Title

Patients with known adrenal insufficiency

Arm Type

Active Comparator

Arm Description

Arm Title

Patients suspected to have adrenal insufficiency

Arm Type

Active Comparator

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Cosyntropin stimulation test

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cortisol threshold with cosyntropin stimulation test

Description

To accurately re-define the cortisol threshold to diagnose adrenal insufficiency with cosyntropin stimulation test using the Alinity, monoclonal antibody, cortisol assay.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Cortisol threshold with basal, morning level

Description

To determine a basal, morning, cortisol level above which adrenal insufficiency can be ruled out using the Alinity cortisol assay.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 cosyntropin stimulation test (peak cortisol level < 18 μg/dL) and current use of physiologic, replacement dose glucocorticoids. 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. Exclusion Criteria for all groups: Moderate to severe liver impairment or abnormal albumin or cortisol binding globulin concentrations Renal impairment with eGFR < 60 mL/min/1.73m2 and/or diagnosis of nephrotic syndrome Pregnancy or nursing mothers Use of estrogen preparations Major depressive disorder, severe malnutrition, anorexia, chronic fatigue syndrome (disorders that alter HPA axis function) Use of any medications that induce hepatic cytochrome P-450 enzymes, e.g., barbiturates, phenytoin, rifampin, amino-glutethimide 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 Be assessed by the investigators as unsuitable for participation in this study for any reason. Additional Exclusion Criteria for healthy volunteers only: Regular use of any oral glucocorticoid (e.g. hydrocortisone, prednisone, dexamethasone) within 6 weeks of the screening visit Use of oral or nasal steroid (glucocorticoid) inhalers in the past 2 weeks Regular use of hydrocortisone cream Use of steroid (glucocorticoid) injections in the past 6 months Regular use of opioids Regular use of suboxone Regular use of megestrol acetate

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Smita B Abraham, MD

Phone

718-920-7247

smabraham@montefiore.org

First Name & Middle Initial & Last Name or Official Title & Degree

Noah Bloomgarden, MD

nbloomga@montefiore.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Smita B Abraham, MD

Organizational Affiliation

Albert Einstein - Montefiore Medical Center, Bronx, New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Smita Abraham, MD

smabraham@montefiore.org

First Name & Middle Initial & Last Name & Degree

Noah Bloomgarden, MD

nbloomga@montefiore.org

First Name & Middle Initial & Last Name & Degree

Smita Abraham, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Updated Diagnostic Cortisol Values for Adrenal Insufficiency

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