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

Study Overview
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Brief Summary
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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

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

Conditions
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Obesity

Intervention / Treatment
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* Other: Salivary Cortisol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (≥18 years) Signed informed consent Subjects affiliated with an appropriate social security system Body mass index above 30 kg/m2 and Pathological waist circumference according to criteria of NCEP ATPIII (men : 94 cm and women : 80 cm) Exclusion Criteria: Pregnancy Sepsis Recent surgery (less than 30 days) Any recent severe acute conditions requiring hospitalisation (less than 30 days) Recent use (< 7 days) of oral steroids, inhaled, dermal, collyrium, infiltration Long-term oral corticosteroids Nicotinic substitute or per os licorice in 2 weeks before the inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Salivary cortisol<br> | Other: Salivary Cortisol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infra-clinic cortisol adenoma, Salivary cortisol, Obesity