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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Salivary cortisol

Group Type OTHER

Salivary Cortisol

Intervention Type OTHER

* 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

Interventions

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Salivary Cortisol

* 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No