Trial Information
Detection of Infra-clinic Cortisol Adenoma (ACIC) in a Population of Android Obese With High Metabolic Risk: Contribution of Salivary Cortisol at 23 Hours
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage
Outcome Description:
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
Safety Issue:
No
Principal Investigator
Bertrand CARIOU, Pr
Investigator Role:
Principal Investigator
Investigator Affiliation:
Nantes University Hospital
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
09/12-I
NCT ID:
NCT01156519
Start Date:
June 2010
Completion Date:
August 2012
Related Keywords:
- Obesity
- Infra-clinic cortisol adenoma
- Salivary cortisol
- Obesity
- Adenoma
- Obesity
