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

This study has been terminated.
(Number of patients with a serum cortisol > 18 ng/ml reached)
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01156519
First received: June 29, 2010
Last updated: July 21, 2014
Last verified: July 2014
  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.


Enrollment: 514
Study Start Date: June 2010
Study Completion Date: March 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156519

Locations
France
Nantes University Hospital
Nantes, France
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: July 21, 2014
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:
Obesity
Adenoma
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on September 18, 2014