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

Nantes University Hospital514 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

514

Conditions

Obesity

Interventions

Salivary CortisolOTHER

* 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nantes University Hospital

Nantes, France

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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