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

Cushings Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02646553
• Other study ID #: 2012/842
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2016
• Last updated: August 14, 2017
• Start date: May 2012
• Est. completion date: April 2019

Study information

• Verified date: August 2017
• Source: Haukeland University Hospital
• Contact: Grethe Åstrøm Ueland, MD
• Phone: 90950021
• Email: geas[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cushing Syndrome
• Cushings Syndrome
• Syndrome

Intervention

Other:
• Children refered to the obesity clinic
Compere if urine cortisol is as good as saliva cortisol as a screening for hypercortisolism in children.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with positive saliva cortisol measurement, not having Cushings syndrome.	Number of patients	2 years
Primary	Number of patients With negative saliva cortisol measurement , having Cushings syndrome.	Number of patients	2 years