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Mass Spectrometry Based Cutoffs for Cortisol After Stimulation Tests

NCT02818660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2024-03-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Synachten

To stimulate the adrenals to increase the cortisol Production as much as possible

Sponsors & Collaborators

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Grethe Åstrøm Ueland, MD · Haukeland University Hopsital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-21
Primary Completion
2017-12-21
Completion
2017-12-21

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02818660 on ClinicalTrials.gov