Clinical Trial: Contribution of Salivary Cortisol in the Detection of Infra-clinic Cortisol Adenoma (ACIC)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Detection of Infra-clinic Cortisol Adenoma (ACIC) in a Population of Android Obese With High Metabolic Risk: Contribution of Salivary Cortisol at 23 Hours

Brief Summary: The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test (Suppression of serum cortisol <1.8 μg/dL ) as the reference method for the detection of ACIC in obese subjects

Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage

The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test as the reference method for the detection of ACIC in obese subjects


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with negative salivary cortisol dosage among patients with negative serum cortisol dosage
    To evaluate specificity, negative predictive value, positive predictive value and diagnostic accuracy of salivary cortisol compared to serum cortisol at 8 am after overnight 1-mg dexamethasone suppression test
  • Comparing the results of salivary cortisol dosage and serum cortisol dosage
    To evaluate concordance between salivary cortisol dosage and serum cortisol dosage
  • Comparing the results of the two salivary samples
    To evaluate the concordance of the two salivary samples
  • Number of patients with metabolic complications of obesity among patients with ACIC
    To evaluate the link between ACIC and metabolic complications of obesity (insulin resistance, IFG, type 2 diabetes, NAFLD…)
  • Number of patients with severe type 2 diabetes among patients with ACIC
    To evaluate the relationship between ACIC and severity of type 2 diabetes, if established.


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: June 29, 2010
Date Started: June 2010
Date Completion:
Last Updated: July 21, 2014
Last Verified: July 2014