Obesity | Contribution of Salivary Cortisol in the Detection of Infra-clinic Cortisol Adenoma (ACIC)
Obesity research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Salivary CortisolDay 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: June 2010
Completed Date: March 2014
Primary Outcome: Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage
Secondary Outcome: Number of patients with negative salivary cortisol dosage among patients with negative serum cortisol dosage
Study sponsors, principal investigator, and references
Principal Investigator: Bertrand CARIOU, Pr
Lead Sponsor: Nantes University Hospital