Obesity Clinical Trial
Official title:
Evaluation of the Diagnostic Utility of Serum Dexamethasone Measurements in the Overnight 1mg Dexamethasone Suppression Test in Patients Investigated for Cushing's Syndrome and Incidentalomas
Background: The evaluation for hypercortisolism includes an overnight 1mg dexamethasone
(DXM) suppression test. An important shortcoming is the diagnostic specificity of only 80%,
which is likely due to inter-individual differences in gut absorption or metabolism of DXM.
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.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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