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

This study is currently recruiting participants.
Verified October 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01156519
First received: June 29, 2010
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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 Intervention
Obesity
Other: Salivary Cortisol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    To evaluate concordance between salivary cortisol dosage and serum cortisol dosage

  • Comparing the results of the two salivary samples [ Designated as safety issue: No ]
    To evaluate the concordance of the two salivary samples

  • Number of patients with metabolic complications of obesity among patients with ACIC [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    To evaluate the relationship between ACIC and severity of type 2 diabetes, if established.


Estimated Enrollment: 525
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156519

Contacts
Contact: Bertrand CARIOU, Pr +33 2 53 48 27 10 bertrand.cariou@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France
Contact: Bertrand CARIOU, Pr    +33 2 53 48 27 10    bertrand.cariou@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Bertrand CARIOU, Pr Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01156519     History of Changes
Other Study ID Numbers: 09/12-I
Study First Received: June 29, 2010
Last Updated: October 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Infra-clinic cortisol adenoma
Salivary cortisol
Obesity

Additional relevant MeSH terms:
Adenoma
Obesity
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014