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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01156519
• Collaborator: (none)
• Enrollment: 514
• Location: 1
• Arm: 1
• Duration (Months): 45
• Patients Per Site Per Month: 11.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Salivary Cortisol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 514 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Detection of Infra-clinic Cortisol Adenoma (ACIC) in a Population of Android Obese With High Metabolic Risk: Contribution of Salivary Cortisol at 23 Hours
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Other: Salivary cortisol

Other: 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Comparing the results of salivary cortisol dosage and serum cortisol dosage []

   To evaluate concordance between salivary cortisol dosage and serum cortisol dosage

3. Comparing the results of the two salivary samples []

   To evaluate the concordance of the two salivary samples

4. 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…)

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Bertrand CARIOU, Pr, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT01156519
• Other Study ID Numbers: 09/12-I
• First Posted: Jul 5, 2010
• Last Update Posted: Jul 22, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Nantes University Hospital: Infra-clinic cortisol adenoma; Salivary cortisol; Obesity
• Additional relevant MeSH terms: Adenoma; Hydrocortisone

Study Results

No Results Posted as of Jul 22, 2014