NCT01156519

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
514

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

3.5 years

First QC Date

June 29, 2010

Last Update Submit

July 21, 2014

Conditions

Obesity

Keywords

Infra-clinic cortisol adenomaSalivary cortisolObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of patients with negative salivary cortisol dosage among patients with negative serum cortisol dosage

  • Comparing the results of salivary cortisol dosage and serum cortisol dosage

  • Comparing the results of the two salivary samples

  • Number of patients with metabolic complications of obesity among patients with ACIC

  • Number of patients with severe type 2 diabetes among patients with ACIC

Study Arms (1)

Salivary cortisol

OTHER
Other: Salivary Cortisol

Interventions

Salivary CortisolOTHER

* 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

Salivary cortisol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bertrand CARIOU, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2010

First Posted

July 5, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

FR(1)