Impact of GH Measurements on GHD Diagnosis

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Brief Title

Impact of GH Measurements on GHD Diagnosis

Official Title

Comparative Study of Human Growth Hormone Measurements: Impact on Clinical Interpretation

Brief Summary

      Human growth hormone (hGH) provocation test is an essential tool to assess growth hormone
      deficiency in children and young adults. It is important to have a robust and reliable method
      to determine the hGH peak of stimulation. This work aimed to compare three common automated
      immunoassays for hGH measurements and to assess whether there are still result-related
      differences influencing clinical decision.
    

Detailed Description

      The investigators analysed GH provocative test of 41 young patients (median age: 12 years)
      from Pediatric Department of Montpellier Hospital, (26 boys and 15 girls), admitted for
      follow-up or for suspicion of growth hormone deficiency. Serum GH of peak concentrations were
      compared using three automated immunoanalyses : COBAS 8000 e602 (ROCHE Diagnostics), IDS-iSYS
      (IDS immunodiagnostic systems) and Liaison XL (Diasorin S.A.).
    


Study Type

Observational


Primary Outcome

Comparative study of human growth hormone measurements

Secondary Outcome

 Stratification of patients based on GH peak secretion

Condition

Growth Hormone Deficiency

Intervention

GH provocation tst


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

41

Start Date

April 1, 2019

Completion Date

November 25, 2019

Primary Completion Date

November 1, 2019

Eligibility Criteria

        Inclusion criteria:

          -  Age<18 years, admitted for suspicion (short stature or growth retardation) or
             follow-up of GHD in pre-and pubertal age

          -  patients undergoing insulin-induced hypoglycaemia stimulation test also called insulin
             tolerance test (ITT)

          -  Exclusion criteria:

          -  Age > 18 years

          -  Patients undergoing different provocation tests
      

Gender

All

Ages

9 Years - 15 Years

Accepts Healthy Volunteers

No

Contacts

Manuela Lotierzo, PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04508673

Organization ID

RECHMPL20_0449


Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier


Study Sponsor

Manuela Lotierzo, PhD, Principal Investigator, UH MONTPELLIER


Verification Date

August 2020