Obesity
Conditions
Keywords
Infra-clinic cortisol adenoma, Salivary cortisol, Obesity
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
Interventions
OTHERSalivary 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
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed