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Trial record 1 of 298 for:    adrenal insufficiency
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Updated Diagnostic Cortisol Values for Adrenal Insufficiency

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ClinicalTrials.gov Identifier: NCT05149638
Recruitment Status : Recruiting
First Posted : December 8, 2021
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Smita B. Abraham, Montefiore Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adrenal Insufficiency Diagnostic Test: Cosyntropin stimulation test Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Re-assessment of Diagnostic Cortisol Values for Adrenal Insufficiency Using a Highly Specific Cortisol Assay
Actual Study Start Date : February 3, 2022
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Healthy volunteers
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.
 Diagnostic Test: Cosyntropin 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.
Active Comparator: Patients with known 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.
 Diagnostic Test: Cosyntropin 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.
Active Comparator: Patients suspected to have 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.
 Diagnostic Test: Cosyntropin 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.


Outcome Measures
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Primary Outcome Measures :
  1. Cortisol threshold with cosyntropin stimulation test [ Time Frame: 2 years ]
    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 :
  1. Cortisol threshold with basal, morning level [ Time Frame: 2 years ]
    To determine a basal, morning, cortisol level above which adrenal insufficiency can be ruled out using the Alinity cortisol assay.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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. Uncontrolled hypo- or hyperthyroidism
  9. Use of biotin within the past 72 hours
  10. Regular alcohol and/or cannabis use

  11. Be assessed by the investigators as unsuitable for participation in this study for any reason.

    Additional Exclusion Criteria for healthy volunteers only:

  12. Regular use of any oral glucocorticoid (e.g. hydrocortisone, prednisone, dexamethasone) within 6 weeks of the screening visit
  13. Use of oral or nasal steroid (glucocorticoid) inhalers in the past 2 weeks
  14. Regular use of hydrocortisone cream
  15. Use of steroid (glucocorticoid) injections in the past 6 months
  16. Regular use of opioids
  17. Regular use of suboxone
  18. Regular use of megestrol acetate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05149638


Contacts
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Contact: Smita B Abraham, MD 718-920-7247 smabraham@montefiore.org
Contact: Noah Bloomgarden, MD nbloomga@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Smita Abraham, MD       smabraham@montefiore.org   
Contact: Noah Bloomgarden, MD       nbloomga@montefiore.org   
Principal Investigator: Smita Abraham, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Smita B Abraham, MD Albert Einstein - Montefiore Medical Center, Bronx, New York
More Information
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Responsible Party: Smita B. Abraham, Associate Profesor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT05149638    
Other Study ID Numbers: 2021-13420
First Posted: December 8, 2021    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Cosyntropin
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs