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Trial · Interventional

CompletedNot applicableRegistry data

Mass Spectrometry Based Cutoffs for Cortisol After Stimulation Tests

NCTNCT02818660 (opens ClinicalTrials.gov in a new tab)Other id2016/174
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
232 participants (actual)
Sponsor
Haukeland University Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Norway

Start
21 May 2016
Primary completion
21 Dec 2017
Completion
21 Dec 2017
First posted
30 Jun 2016 (estimated)
Last update posted
1 Mar 2024
Conditions
Adrenal Insufficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. N/A

    Mass Spectrometry Based Cutoffs for Cortisol After Stimulation Tests

    NCT02818660

    21 May 2016 to 21 Dec 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SynachtenDrug

Arms1

  • Experimental

    Synacthen

    The patient get Synacthen to stimulate the adrenals to produce cortisol

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Define a cutoff level for serum cortisol after stimulation with synacthen or hypoglycemia in healthy control persons.

    Time frame · 2 year

    Registry description

    s-cortisol

Secondary outcomes(3)

  1. Define a cutoff level for serum 17-OH-progesterone after stimulation with synacthen or hypoglycemia in healthy control persons.

    Time frame · 2 year

    Registry description

    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

    Registry description

    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

    Registry description

    saliva 17-OH-progesterone

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

PubMed tag: none · 2022

Adrenal steroid profiling as a diagnostic tool to differentiate polycystic ovary syndrome from nonclassic congenital adrenal hyperplasia: pinpointing easy screening possibilities and normal cutoff levels using liquid chromatography tandem mass spectrometry.

GÅ et al. 2022Fertility and sterilitycited by 12

PMID 35725670DOI 10.1016/j.fertnstert.2022.05.012PUB-35725670

Full text at the publisher
Publisher page

PubMed tag: none · 2018

The Short Cosyntropin Test Revisited: New Normal Reference Range Using LC-MS/MS.

GÅ et al. 2018The Journal of clinical endocrinology and metabolismcited by 50

PMID 29452421DOI 10.1210/jc.2017-02602PUB-29452421

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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