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Does Serum-DXM Increase Diagnostic Accuracy of the Overnight DXM Suppression Test in the Work-up of Cushing's Syndrome? (DXM)

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ClinicalTrials.gov Identifier: NCT01504555
Recruitment Status : Unknown
Verified September 2016 by Haukeland University Hospital.
Recruitment status was:  Recruiting
First Posted : January 5, 2012
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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Brief Summary:

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.


Condition or disease
Cushing's Syndrome Adrenal Incidentalomas Alcoholism Obesity

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : October 2011
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

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Groups and Cohorts
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Group/Cohort
Patients under investigation for hypercortisolism
Patients undergoing routine evaluation for hypercortisolism at Haukeland University Hospital, Bergen, Norway, will be asked to participate.


Outcome Measures
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Primary Outcome Measures :
  1. The difference (in percent) in false positive DXM-tests comparing the outcome of all tests with all tests excluding those with s-DXM below the the cut-off specified below. [ Time Frame: 1 year ]

    The s-DXM cut-off will be defined a priori from ROC analysis on patients that inadequately suppress s-cortisol categorized as having Cushing's syndrome or being healthy.

    DXM, dexamethasone; DXM-test, short 1mg dexamethasone suppression test.



Secondary Outcome Measures :
  1. Calculate the positive likelihood ratio [(1-sensitivity)/specificity] for the short DXM-test in the assessment of Cushing's syndrome (CS), after excluding those with s-DXM below the DXM cut-off specified in the primary endpoint. [ Time Frame: 1 year ]

    Sensitivity = (Number of patients having CS with positive test / total number of patients with CS).

    Specificity = (Number of patients not having CS with negative test / total number of patients not having CS).


  2. Calculate the negative likelihood ratio [(1-sensitivity)/specificity] for the short DXM-test in the assessment of Cushing's syndrome, after excluding those with s-DXM below the DXM cut-off specified in the primary endpoint. [ Time Frame: 1 year ]
  3. Calculate the positive likelihood ratio [(1-sensitivity)/specificity] for midnight salivary cortisol in the assessment of Cushing's syndrome. All study cases are included in this analysis. [ Time Frame: 1 year ]
  4. Calculate the negative likelihood ratio [(1-sensitivity)/specificity] for midnight salivary cortisol in the assessment of Cushing's syndrome. All study cases are included in this analysis. [ Time Frame: 1 year ]
    A saliva cortisol cut-off level will be defined a priori from ROC analysis on all patients with and without Cushing's syndrome.

  5. Calculate the positive likelihood ratio [(1-sensitivity)/specificity] for midnight salivary cortisone in the assessment of Cushing's syndrome. All study cases are included in this analysis. [ Time Frame: 1 year ]
    A saliva cortisone cut-off level will be defined a priori from ROC analysis on all patients with and without Cushing's syndrome.

  6. Calculate the negative likelihood ratio [(1-sensitivity)/specificity] for midnight salivary cortisone in the assessment of Cushing's syndrome. All study cases are included in this analysis. [ Time Frame: 1 year ]
    A saliva cortisone cut-off level will be defined a priori from ROC analysis on all patients with and without Cushing's syndrome.

  7. Identical to primary endpoint, but saliva-DXM measurements replace serum-DXM. [ Time Frame: 1 year ]
  8. Identical to primary endpoint, but saliva-DXM measurements replace serum-DXM, and saliva-cortisol replace serum-cortisol. [ Time Frame: 1 year ]
  9. Identical to primary endpoint, but saliva-DXM measurements replace serum-DXM and saliva-cortisone replace serum-cortisol. [ Time Frame: 1 year ]
  10. Calculate the positive likelihood ratio [(1-sensitivity)/specificity] for creatinine-adjusted cortisol in morning spot urine in the assessment of Cushing's syndrome. All study cases are included in this analysis. [ Time Frame: 1 year ]
    A cut-off level for creatinine-adjusted morning urine cortisol will be defined a priori from ROC analysis on all patients with and without Cushing's syndrome.

  11. Calculate the negative likelihood ratio [(1-sensitivity)/specificity] for creatinine-adjusted cortisol in morning spot urine in the assessment of Cushing's syndrome. All study cases are included in this analysis. [ Time Frame: 1 year ]
    A cut-off level for creatinine-adjusted morning urine cortisol will be defined a priori from ROC analysis on all patients with and without Cushing's Syndrome.

  12. Compute a 95% confidence interval for morning s-DXM following overnight DXM-test in healthy subjects using parametric and non-parametric statistics. [ Time Frame: 1 year ]
  13. Quantitatively and qualitatively describe the characteristics of patients with false positive DXM-test and true negative DXM-test based on a standard questionnaire scoring patient history, symptoms and clinical features. [ Time Frame: 1 year ]
    Parametric descriptive statistics

  14. Evaluate the dexamethasone metabolism in patients with obesity [ Time Frame: 1 year ]
    We are evaluating if overweight patients metabolise Dexamethasone in the same way as normal weighted patients, by looking at the s-dexamethasone and s-cortisol level the day after 1 mg overnight Dexamethason suppression test.

  15. Evaluate the dexamethasone metabolism in patients with alcohol abuse [ Time Frame: 1 year ]
    We are evaluating if patients with alcohol abuse metabolise dexamethasone in the same way as normal patients, by looking at the s-dexamethasone and s-cortisol level the day after 1 mg overnight dexamethason suppression test.


Biospecimen Retention:   Samples Without DNA
Blood, saliva, urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients at Haukeland University Hosptial, Bergen, Norway, under routine evaluation for hypercortisolism.Patients under evaluation for obeity at the overweight clinic, and Patients treated for alcohol abuse at the clinic for alcohol addicts at Haukeland University hospital.
Criteria

Inclusion Criteria:

  • Age over 18 years
  • Under investigation for hypercortisolism
  • Able and willing to make informed consent

Exclusion Criteria:

  • Use of systemic or local glucocorticoids
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504555


Contacts
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Contact: Grethe Åstrøm Ueland, MD +4790950021 geas@helse-bergen.no
Contact: Paal Methli, MD +4797677930

Locations
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Norway
Haukeland Universitetssykehus- Rusmedisinsk avdeling Not yet recruiting
Bergen, Norway, 5019
Contact: Pia Synøve Kloster, Cand.med    55975000      
Sub-Investigator: Pia Synøve Kloster, Cand.med         
Haukeland Universitetssykehus- Endokrinologisk avdeling Recruiting
Bergen, Norway, 5021
Contact: Grethe Åstrøm Ueland, Doctor    +4790950021    geas@helse-bergen.no   
Contact: Hrafnkell Baldur Thordarsson, Doctor    +4755972995    hraf@helse-bergen.no   
Principal Investigator: Grethe Ueland, MD         
Sub-Investigator: Hrafnkell Baldur Thordarsson, MD         
Sub-Investigator: Eystein Husebye, Prof.Dr.Med         
Sub-Investigator: Kristian Løvås, Prof.Dr.Med         
Institutt for farmakologi Recruiting
Bergen, Norway, 5021
Contact: Simon Steinar Hustad, Dr.Med         
Haukeland University Hospital- Hormonlaboratory Recruiting
Bergen, Norway, 5096
Contact: Grethe Åstrøm Ueland, Doctor    +4790950021    geas@helse-bergen.no   
Contact: Paal Methli, Doctor    +4797677930      
Principal Investigator: Grethe Åstrøm Ueland, Doctor         
Sub-Investigator: Paal Methli, Doctor         
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Study Chair: Grethe Åstrøm Ueland, MD Haukeland University Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01504555    
Other Study ID Numbers: 2011/1810
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Keywords provided by Haukeland University Hospital:
hypercortisolism, dexamethasone, alcoholism,obesity.
Additional relevant MeSH terms:
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Adrenocortical Adenoma
Cushing Syndrome
Syndrome
Alcoholism
Disease
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
 Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Cortex Diseases