An interventional study of Salivary Cortisol in Obesity, sponsored by Nantes University Hospital. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-22.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Diagnostic
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
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 514 is above the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
Other: Salivary Cortisol
* Day 1: 1st salivary cortisol at 23 hours * Day 2: 2nd salivary cortisol at 23 hours and administration of dexamethasone (for overnight 1-mg dexamethasone suppression test) * Day 3: serum cortisol at 8 am * Between Day 4 and Month 3: if serum cortisol at 8 am \> 18ng/mL: * Cortisol for 24 hours * dexamethasone suppression test (2mg/j during 2 days) * Cortisol and ACTH cycle * Noriodocholesterol scintigraphy
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
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.
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital