Impact of GH Measurements on GHD Diagnosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04508673

Enrollment

Registered

2020-08-11

Start date

2019-04-01

Completion date

2019-11-25

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

Keywords

growth hormone deficiency, immunoanalysis, hGH provocation test, diagnosis

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.).

Interventions

OTHERGH 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).

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Years to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comparative study of human growth hormone measurements	1 day	Comparative study of human growth hormone measurements by using three different automated immunoassays

Secondary

Measure	Time frame	Description
Stratification of patients based on GH peak secretion	1 day	Stratification of patients based on GH peak secretion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026