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

Obesity Clinical Trial

— ACIC  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01156519
• Other study ID #: 09/12-I
• Status: Terminated
• Phase: N/A
• First received: June 29, 2010
• Last updated: July 21, 2014
• Start date: June 2010
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 514
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No
Secondary	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		No
Secondary	Comparing the results of salivary cortisol dosage and serum cortisol dosage	To evaluate concordance between salivary cortisol dosage and serum cortisol dosage		No
Secondary	Comparing the results of the two salivary samples	To evaluate the concordance of the two salivary samples		No
Secondary	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…)		No
Secondary	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.		No