Saliva Cortisol Measurement as a Screening Test for Suspicious Cushings Syndrome in Children.

• Conditions: Cushings Syndrome
• Interventions: Other: Children refered to the obesity clinic

• Registration Number: NCT02646553
• Lead Sponsor: Haukeland University Hospital

Brief Summary

Cortisol overproduction ( Cushings syndrome) is a condition where the patient have a special fat distribution, with accumulation of fat around the abdomen and in the neck, with thinner limbs and weak musculature. The condition can be difficult to separate from adipositas in general. Screening for hypercortisolism in adults has been easier the last years, because we can measure free cortisol in saliva samples at late night. In children we still dont have reference ranges for saliva cortisol in children, so the screening is still troublesome, based on Collection of 24-hour urine.The meaning of this study is to establish reference ranges for saliva cortisol, and evaluate in a cohort with adipose children if screening with saliva cortisol is sensitive and specific enough to be the New screening test for hypercortisolism in children too.

Detailed Description

the investigators have collected saliva samples morning and late evening for cortisol measurements in a total of 330 children ( 660 samples) in the age from 4 to 16 years ols. This samples are going to be used to define a reference range for saliva cortisol in children.

The investigators are then collecting 24 hour urine and saliva samples ( morning and late evening) from children at the obesity clinic Haukeland University hospital for verification of the reference range , and to estimate if the test is good enough to identify the patients that have Cushings syndrome.

Since the diagnose is very seldom in children, we will get help from a 3. line referral center in London to include patients with true Cushings syndrome.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Children aged 4-16 years. Healthy population from selected kindergarten and Schools, and patients refered to the obesity clinic Haukeland University Hospital, for examination and optionally treatment.

Exclusion Criteria

Use of any kind of steroids ( oral, liniments, inhalations etc)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children refered to the obesity clinic.	Children refered to the obesity clinic	All children refered to the obesity clinic for examination and optionally treatment are invited.

Primary Outcome Measures

Name	Time	Method
Number of patients With negative saliva cortisol measurement , having Cushings syndrome.	2 years	Number of patients
Number of patients with positive saliva cortisol measurement, not having Cushings syndrome.	2 years	Number of patients

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway