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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02646553
Enrollment
70
Registered
2016-01-05
Start date
2012-05-31
Completion date
2019-04-30
Last updated
2017-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushings Syndrome

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.

Interventions

OTHERChildren refered to the obesity clinic

Compere if urine cortisol is as good as saliva cortisol as a screening for hypercortisolism in children.

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No

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) \-

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with positive saliva cortisol measurement, not having Cushings syndrome.2 yearsNumber of patients
Number of patients With negative saliva cortisol measurement , having Cushings syndrome.2 yearsNumber of patients

Countries

Norway

Contacts

Primary ContactGrethe Åstrøm Ueland, MD
geas@helse-bergen.no90950021
Backup ContactGunnar Mellgren, Prof.
gunm@helse-bergen.no55974366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026