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

Information source: Nantes University Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Salivary Cortisol (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Nantes University Hospital

Official(s) and/or principal investigator(s):
Bertrand CARIOU, Pr, Principal Investigator, Affiliation: Nantes University Hospital

Overall contact:
Bertrand CARIOU, Pr, Phone: +33 2 53 48 27 10, Email: bertrand.cariou@chu-nantes.fr

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Number of patients with positive salivary cortisol dosage among patients with positive serum cortisol dosage

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Nantes University Hospital, Nantes, France; Recruiting
Bertrand CARIOU, Pr, Phone: +33 2 53 48 27 10, Email: bertrand.cariou@chu-nantes.fr
Additional Information

Starting date: June 2010
Last updated: July 2, 2010

Page last updated: October 04, 2010

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