Impact of GH Measurements on GHD Diagnosis

NCT ID: NCT04508673

Last Updated: 2020-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-11-25

Brief Summary

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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

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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.).

Conditions

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Growth Hormone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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GH provocation tst

All patients underwent insulin-induced hypoglycaemia stimulation test also called insulin tolerance test (ITT), considered the 'gold standard' test for GHD diagnosis. Following insulin administration by venipuncture (1UI/mL), levels of hGH and glucose were monitored on serum and fluoride tube plasma, respectively, at intervals of 0, 30, 45, 60 and 90 minutes (T0, T30, T45, T60 and T90).

Intervention Type OTHER

Other Intervention Names

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reliquens of serum samples from GH provocation test

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuela Lotierzo, PhD

Role: PRINCIPAL_INVESTIGATOR

UH MONTPELLIER

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

References

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Lotierzo M, Olaru-Soare F, Dupuy AM, Plawecki M, Paris F, Cristol JP. Comparative study of human growth hormone measurements: impact on clinical interpretation. Clin Chem Lab Med. 2021 Dec 2;60(2):191-197. doi: 10.1515/cclm-2021-1109. Print 2022 Jan 27.

Reference Type DERIVED
PMID: 34850616 (View on PubMed)

Other Identifiers

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RECHMPL20_0449

Identifier Type: -

Identifier Source: org_study_id

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