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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
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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. Use of oral or nasal steroid inhalers in the past two weeks (healthy volunteers and patients with known adrenal insufficiency only)*
  9. Regular use of hydrocortisone cream.
  10. Use of steroid injections in the past 6 months (healthy volunteers and patients with known adrenal insufficiency only) *
  11. Regular use of alcohol (healthy volunteers and patients with known adrenal insufficiency only)*
  12. Regular use of opioids (healthy volunteers and patients with known adrenal insufficiency only)*
  13. Regular use of suboxone (healthy volunteers and patients with known adrenal insufficiency only)*
  14. Regular use of megestrol acetate (healthy volunteers and patients with known adrenal insufficiency only)*
  15. Use of biotin in the past 72 hours
  16. Uncontrolled hypo- or hyperthyroidism

Sites / Locations

  • Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

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

First Posted
November 24, 2021
Last Updated
January 23, 2023
Sponsor
Montefiore Medical Center
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
Arm Title
Patients with known adrenal insufficiency
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patients suspected to have adrenal insufficiency
Arm Type
Active Comparator
Arm Description
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.
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
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
Email
smabraham@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Noah Bloomgarden, MD
Email
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
Email
smabraham@montefiore.org
First Name & Middle Initial & Last Name & Degree
Noah Bloomgarden, MD
Email
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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