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Mass Spectrometry Based Cutoffs for Cortisol After Stimulation Tests

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ClinicalTrials.gov Identifier: NCT02818660
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adrenal Insufficiency Drug: Synachten Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Mass Spectrometry Based Cutoffs for Cortisol and 17-hydroxy-progesterone (17-OH-progesterone) After Stimulation Tests for Primary and Secondary Adrenal Insufficiency.
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018


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 Name: tetracosactide




Primary Outcome Measures :
  1. Define a cutoff level for serum cortisol after stimulation with synacthen or hypoglycemia in healthy control persons. [ Time Frame: 2 year ]
    s-cortisol


Secondary Outcome Measures :
  1. 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. Define a cutoff level for saliva cortisol after stimulation with synacthen or hypoglycemia in healthy control persons. [ Time Frame: 2 year ]
    saliva cortisol

  3. 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



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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:

  • 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.


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): NCT02818660


Contacts
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Contact: Grethe Åstrøm Ueland, MD +4790950021 geas@helse-bergen.no
Contact: Eystein Husebye, MD, Prof. +47559750000 eyhu@helse-bergen.no

Locations
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Norway
Haukeland University hopsital Recruiting
Bergen, Norway, 5019
Contact: Grethe Ueland, MD    +4790950021    geas@helse-bergen.no   
Contact: Hrafnkell Thordasron, MD    +4755972955    hraf@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Principal Investigator: Grethe Åstrøm Ueland, MD Haukeland University Hopsital

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02818660     History of Changes
Other Study ID Numbers: 2016/174
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents