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

H

Haukeland University Hospital

Status

Unknown

Conditions

Cushings Syndrome

Treatments

Other: Children refered to the obesity clinic

Study type

Observational

Funder types

Other

Identifiers

NCT02646553
2012/842

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

70 participants in 1 patient group

Children refered to the obesity clinic.
Description:
All children refered to the obesity clinic for examination and optionally treatment are invited.
Treatment:
Other: Children refered to the obesity clinic

Trial contacts and locations

1

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Central trial contact

Gunnar Mellgren, Prof.; Grethe Åstrøm Ueland, MD

Data sourced from clinicaltrials.gov

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