NCT02818660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

June 14, 2016

Last Update Submit

February 29, 2024

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

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

    s-cortisol

    2 year

Secondary Outcomes (3)

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

    2 year

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

    2 year

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

    2 year

Study Arms (1)

Synacthen

EXPERIMENTAL

The patient get Synacthen to stimulate the adrenals to produce cortisol

Drug: Synachten

Interventions

SynachtenDRUG

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

Also known as: tetracosactide
Synacthen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Use of corticosteroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University hopsital

Bergen, 5019, Norway

Location

Related Publications (2)

  • Ueland GA, Methlie P, Oksnes M, Thordarson HB, Sagen J, Kellmann R, Mellgren G, Raeder M, Dahlqvist P, Dahl SR, Thorsby PM, Lovas K, Husebye ES. The Short Cosyntropin Test Revisited: New Normal Reference Range Using LC-MS/MS. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1696-1703. doi: 10.1210/jc.2017-02602.

    PMID: 29452421RESULT

  • Ueland GA, Dahl SR, Methlie P, Hessen S, Husebye ES, Thorsby PM. 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. Fertil Steril. 2022 Aug;118(2):384-391. doi: 10.1016/j.fertnstert.2022.05.012. Epub 2022 Jun 18.

    PMID: 35725670RESULT

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Cosyntropin

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Adrenocorticotropic HormoneMelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Grethe Åstrøm Ueland, MD

    Haukeland University Hopsital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 30, 2016

Study Start

May 21, 2016

Primary Completion

December 21, 2017

Study Completion

December 21, 2017

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)