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

N

Nantes University Hospital (NUH)

Status

Terminated

Conditions

Obesity

Treatments

Other: Salivary Cortisol

Study type

Interventional

Funder types

Other

Identifiers

NCT01156519
09/12-I

Details and patient eligibility

About

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

Enrollment

514 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

514 participants in 1 patient group

Salivary cortisol
Other group
Treatment:
Other: Salivary Cortisol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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