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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Obesity

Treatments: Other: Salivary Cortisol

Study type: Interventional

Funder types: Other

Identifiers

NCT01156519

09/12-I

Details and patient eligibility

About

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

Enrollment: 514 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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514 participants in 1 patient group

Salivary cortisol

Other group

Treatment:

Other: Salivary Cortisol