Mass Spectrometry Based Cutoffs for Cortisol After Stimulation Tests

February 29, 2024 updated by: Haukeland University Hospital

Mass Spectrometry Based Cutoffs for Cortisol and 17-hydroxy-progesterone (17-OH-progesterone) After Stimulation Tests for Primary and Secondary Adrenal Insufficiency.

There are two main stimulation tests used to decide if a patient has cortisol deficiency. It is the "synacthen test", were we stimulate the patient with intramuscular or intravenous synacthen ( ACTH) to see how much cortisol the adrenals are capable of producing, and it is the "Insulin hypoglycemia test" were we give the patient insulin to provoke a hypoglycemia, and look at the adrenal response to that stimulus. The cut off values for a normal response is based on old immunological assays no longer in use. Assays with a lot of interference and cross reactivity leading to measurement of higher values for cortisol than what we measure on the highly specific LCMS/MS ( Liquid chromatography mass spectrometry methode) that we are using for cortisol today. So, there is a need for new cut off values for a normal response to such tests. The purpose of this study is to produce such new cutoff values by performing the test in 120 healthy controls. We also want to perform the test in patient groups normally going trough this tests according to the same protocol as the control persons, to evaluate the new cutoffs in different patient groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

120 healthy controls will perform an intravenous synacthen test in our out patient clinic. We register anthropometric data, and take basal blood screening to assure they are healthy. We take basal blood and saliva samples right before start of the test ( called 0-samples). Then they get intravenous synacthen, and we take new samples at 30 minutes and 60 minutes. They are observed during the procedure. We will then calculate a new cut off value for cortisol after the test, based on the 2.5 percentile for cortisol in this population. We will also calculate the same for 17-OH-progesterone, a parameter we also look at after synacthen test in som patient groups ( patients with hirsutism, who are suspicious of having an enzyme defect in the cortisol synthesis cascade). The saliva samples will also be analyzed for cortisol and 17-OH-progesterone, to evaluate if it is possible to use saliva instead of blood samples in synacthen tests in the future. The advantage of using saliva samples is that they can be used also in patients with elevated amount of cortisol binding globulin (CBG), because it measure the free hormone that is biological active ( not both the free and the protein bound, as we measure in serum samples). This is important in patients on estrogens , and in pregnant women, that have large amount of CBG.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5019
        • Haukeland University hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy individuals not using any corticosteroids .
  • Patients with clinical suspicion of primary or secondary adrenal insufficiency. -Patient suspicious of having an enzyme defect ( 21 hydroxylase deficiency) giving hirsutism.

Exclusion Criteria:

-Use of corticosteroids.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synacthen
The patient get Synacthen to stimulate the adrenals to produce cortisol
Drug: Synachten
To stimulate the adrenals to increase the cortisol Production as much as possible
Other Names:
  • tetracosactide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define a cutoff level for serum cortisol after stimulation with synacthen or hypoglycemia in healthy control persons.
Time Frame: 2 year
s-cortisol
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define a cutoff level for serum 17-OH-progesterone after stimulation with synacthen or hypoglycemia in healthy control persons.
Time Frame: 2 year
s-17-OH-progesterone
2 year
Define a cutoff level for saliva cortisol after stimulation with synacthen or hypoglycemia in healthy control persons.
Time Frame: 2 year
saliva cortisol
2 year
Define a cutoff level for saliva 17-OH-progesterone after stimulation with synacthen or hypoglycemia in healthy control persons.
Time Frame: 2 year
saliva 17-OH-progesterone
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Grethe Åstrøm Ueland, MD, Haukeland University hopsital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2016

Primary Completion (Actual)

December 21, 2017

Study Completion (Actual)

December 21, 2017

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimated)

June 30, 2016

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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