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

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.

Study Overview

• Status: Unknown
• Conditions: Cushings Syndrome
• Intervention / Treatment: Other: Children refered to the obesity clinic

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.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Grethe Åstrøm Ueland, MD; Phone Number: +47 90950021; Email: geas@helse-bergen.no
• Study Contact Backup: Name: Gunnar Mellgren, Prof.; Phone Number: +47 55974366; Email: gunm@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Grethe Ueland, MD; Phone Number: +4790950021; Email: geas@helse-bergen.no
    • Contact: Gunnar Mellgren, MD; Phone Number: +4755974366; Email: gunm@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

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Exclusion Criteria:Use of any kind of steroids ( oral, liniments, inhalations etc)

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Compere if urine cortisol is as good as saliva cortisol as a screening for hypercortisolism in children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Grethe Åstrøm Ueland, MD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Syndrome; Cushing Syndrome
• Other Study ID Numbers: 2012/842