Saliva Cortisol Measurement as a Screening Test for Suspicious Cushings Syndrome in Children.
1 other identifier
observational
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 4, 2016
CompletedFirst Posted
Study publicly available on registry
January 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedAugust 16, 2017
August 1, 2017
6.9 years
January 4, 2016
August 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients with positive saliva cortisol measurement, not having Cushings syndrome.
Number of patients
2 years
Number of patients With negative saliva cortisol measurement , having Cushings syndrome.
Number of patients
2 years
Study Arms (1)
Children refered to the obesity clinic.
All children refered to the obesity clinic for examination and optionally treatment are invited.
Interventions
Compere if urine cortisol is as good as saliva cortisol as a screening for hypercortisolism in children.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haukeland University Hospital
Bergen, 5021, Norway
Biospecimen
the investigators collect saliva and urine from the patients, for analysis of the hormone cortisol.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grethe Åstrøm Ueland, MD
Haukeland University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2016
First Posted
January 5, 2016
Study Start
May 1, 2012
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
August 16, 2017
Record last verified: 2017-08