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

This study is currently recruiting participants.
Verified August 2017 by Haukeland University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02646553
First Posted: January 5, 2016
Last Update Posted: August 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Haukeland University Hospital
  Purpose
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.

Condition Intervention
Cushings Syndrome Other: Children refered to the obesity clinic

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Saliva Cortisol Measurement as a Screening Test for Suspicious Cushings Syndrome in Children.

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Number of patients with positive saliva cortisol measurement, not having Cushings syndrome. [ Time Frame: 2 years ]
    Number of patients

  • Number of patients With negative saliva cortisol measurement , having Cushings syndrome. [ Time Frame: 2 years ]
    Number of patients


Biospecimen Retention:   Samples Without DNA
the investigators collect saliva and urine from the patients, for analysis of the hormone cortisol.

Estimated Enrollment: 70
Study Start Date: May 2012
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   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.
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)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646553


Contacts
Contact: Grethe Åstrøm Ueland, MD 90950021 ext +47 geas@helse-bergen.no
Contact: Gunnar Mellgren, Prof. 55974366 ext +47 gunm@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Grethe Ueland, MD    +4790950021    geas@helse-bergen.no   
Contact: Gunnar Mellgren, MD    +4755974366    gunm@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Grethe Åstrøm Ueland, MD Haukeland University Hospital
  More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02646553     History of Changes
Other Study ID Numbers: 2012/842
First Submitted: January 4, 2016
First Posted: January 5, 2016
Last Update Posted: August 16, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents