Clinical Trial: Saliva Cortisol Measurement as a Screening Test for Suspicious Cushings Syndrome in Children.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Saliva Cortisol Measurement as a Screening Test for Suspicious Cushings Syndrome in Children.
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 Summary:
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.
Sponsor: Haukeland University Hospital
Current Primary Outcome:
- Number of patients with positive saliva cortisol measurement, not having Cushings syndrome. [ Time Frame: 2 years ]
- Number of patients With negative saliva cortisol measurement , having Cushings syndrome. [ Time Frame: 2 years ]
Original Primary Outcome: Validation of saliva cortisol as a screening test for hypercortisoim in children [ Time Frame: 2 years ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Haukeland University Hospital
Dates:
Date Received: January 4, 2016
Date Started: May 2012
Date Completion: December 2016
Last Updated: September 7, 2016
Last Verified: September 2016
