Does Serum-DXM Increase Diagnostic Accuracy of the Overnight DXM Suppression Test in the Work-up of Cushing's Syndrome?
NCT ID: NCT01504555
Last Updated: 2016-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2011-10-31
2017-09-30
Brief Summary
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Study hypothesis: The investigators hypothesize that serum-DXM measurements will increase the diagnostic accuracy of the overnight DXM-test in the work-up of hypercortisolism.
Aims: The primary aim of this prospective study is to evaluate if serum-DXM measured simultaneously with serum-cortisol in morning samples could increase the diagnostic accuracy this diagnostic test. There are several secondary aims. One is to estimate the prevalence and causes of unusual DXM absorption or metabolism. The investigators will also evaluate the feasibility and diagnostic accuracy of salivary DXM. Moreover, the diagnostic accuracy of midnight salivary cortisol and cortisone, and urinary cortisol, will be evaluated and compared.
Design: Levels of DXM in morning serum following an overnight DXM-test will be analyzed in patients under evaluation for hypercortisolism (including incidentalomas). A cut-off level to identify inadequate DXM concentrations in serum to suppress endogenous cortisol production will be established based on the negative tests. This cut-off level will then be applied in a retrospective analysis of the diagnostic accuracy of DXM-tests. This prospective study has a blinded design as the DXM measurements are disclosed after the end of the trial.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients under investigation for hypercortisolism
Patients undergoing routine evaluation for hypercortisolism at Haukeland University Hospital, Bergen, Norway, will be asked to participate.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Under investigation for hypercortisolism
* Able and willing to make informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Grethe Åstrøm Ueland, MD
Role: STUDY_CHAIR
Haukeland University Hospital
Locations
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Haukeland Universitetssykehus- Rusmedisinsk avdeling
Bergen, , Norway
Haukeland Universitetssykehus- Endokrinologisk avdeling
Bergen, , Norway
Institutt for farmakologi
Bergen, , Norway
Haukeland University Hospital- Hormonlaboratory
Bergen, , Norway
Countries
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Central Contacts
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Paal Methli, MD
Role: CONTACT
Facility Contacts
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Pia Synøve Kloster, Cand.med
Role: primary
Simon Steinar Hustad, Dr.Med
Role: primary
Paal Methli, Doctor
Role: backup
References
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Baid SK, Rubino D, Sinaii N, Ramsey S, Frank A, Nieman LK. Specificity of screening tests for Cushing's syndrome in an overweight and obese population. J Clin Endocrinol Metab. 2009 Oct;94(10):3857-64. doi: 10.1210/jc.2008-2766. Epub 2009 Jul 14.
Nieman LK, Biller BM, Findling JW, Newell-Price J, Savage MO, Stewart PM, Montori VM. The diagnosis of Cushing's syndrome: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2008 May;93(5):1526-40. doi: 10.1210/jc.2008-0125. Epub 2008 Mar 11.
Carroll TB, Findling JW. The diagnosis of Cushing's syndrome. Rev Endocr Metab Disord. 2010 Jun;11(2):147-53. doi: 10.1007/s11154-010-9143-3.
Related Links
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Kortisol i spytt ved sykdom i binyrene
Spyttprøver til kortisolmåling
Endogent Cushing syndrom
Other Identifiers
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2011/1810
Identifier Type: -
Identifier Source: org_study_id
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