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

NCT ID: NCT02646553

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2019-04-30

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.

Conditions

Cushings Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Children refered to the obesity clinic.

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

Children refered to the obesity clinic

Intervention Type: OTHER

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

Interventions

Children refered to the obesity clinic

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grethe Åstrøm Ueland, MD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Grethe Åstrøm Ueland, MD

Role: CONTACT

geas@helse-bergen.no

90950021 ext. +47

Gunnar Mellgren, Prof.

Role: CONTACT

gunm@helse-bergen.no

55974366 ext. +47

Facility Contacts

Grethe Ueland, MD

Role: primary

geas@helse-bergen.no

+4790950021

Gunnar Mellgren, MD

Role: backup

gunm@helse-bergen.no

+4755974366

Other Identifiers

2012/842

Identifier Type: -

Identifier Source: org_study_id