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Status unknownNCT02646553Updated Aug 16, 2017

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

An observational study in Cushings Syndrome, sponsored by Haukeland University Hospital. Status unknown at 1 site in Norway. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2017-08-16.

Sponsored by Haukeland University Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
70
Ages
4 Years to 16 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cushings Syndrome
03

In context

Cushing Syndrome

123 studies on the registry are indexed under Cushing Syndrome; 37 are open to participants now.

This study's planned enrollment of 70 is below the median of 115 across 62 observational studies indexed under Cushing Syndrome.

Browse Cushing Syndrome studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The reference are made from healthy children included from kindergarden and Schools in the Bergen area. The age range from 4 to 16 years ols. The patient population is children refered to the obestity clinic at Haukeland University Hospital.

Eligibility 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)

-

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Children refered to the obesity clinic.

    All children refered to the obesity clinic for examination and optionally treatment are invited.

    Other: Children refered to the obesity clinic

Interventions

  • OtherChildren refered to the obesity clinic

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

06

What researchers measure

Primary outcomes

  1. Number of patients with positive saliva cortisol measurement, not having Cushings syndrome.

    Number of patients

    Time frame: 2 years

  2. Number of patients With negative saliva cortisol measurement , having Cushings syndrome.

    Number of patients

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02646553
Lead sponsor
Haukeland University Hospital
Responsible party
Sponsor
First posted
Jan 5, 2016
Start date
May 2012
Primary completion
Apr 2019 (estimated)
Completion
Apr 2019 (estimated)
Last update
Aug 16, 2017

Study contacts

Grethe Åstrøm Ueland, MD
Contact
geas@helse-bergen.no
90950021 ext. +47
Gunnar Mellgren, Prof.
Contact
gunm@helse-bergen.no
55974366 ext. +47
Grethe Åstrøm Ueland, MD
principal investigator · Haukeland University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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