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

Primary Purpose

Obesity

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Salivary Cortisol
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity focused on measuring Infra-clinic cortisol adenoma, Salivary cortisol, Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Salivary cortisol

Arm Description

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
June 29, 2010
Last Updated
July 21, 2014
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01156519
Brief Title
Contribution of Salivary Cortisol in the Detection of Infra-clinic Cortisol Adenoma (ACIC)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Number of patients with a serum cortisol > 18 ng/ml reached
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Infra-clinic cortisol adenoma, Salivary cortisol, Obesity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
514 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salivary cortisol
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Salivary Cortisol
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage
Description
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 Measure Information:
Title
Number of patients with negative salivary cortisol dosage among patients with negative serum cortisol dosage
Description
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
Title
Comparing the results of salivary cortisol dosage and serum cortisol dosage
Description
To evaluate concordance between salivary cortisol dosage and serum cortisol dosage
Title
Comparing the results of the two salivary samples
Description
To evaluate the concordance of the two salivary samples
Title
Number of patients with metabolic complications of obesity among patients with ACIC
Description
To evaluate the link between ACIC and metabolic complications of obesity (insulin resistance, IFG, type 2 diabetes, NAFLD…)
Title
Number of patients with severe type 2 diabetes among patients with ACIC
Description
To evaluate the relationship between ACIC and severity of type 2 diabetes, if established.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand CARIOU, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France

12. IPD Sharing Statement

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

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