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

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Other: Salivary Cortisol

• Registration Number: NCT01156519
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 514

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salivary cortisol	Salivary Cortisol	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Comparing the results of the two salivary samples		To evaluate the concordance of the two salivary samples
Comparing the results of salivary cortisol dosage and serum cortisol dosage		To evaluate concordance between salivary cortisol dosage and serum cortisol dosage
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
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.

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France