NCT04508673

Impact of GH Measurements on GHD Diagnosis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 9 Years – 15 Years
• Healthy volunteers: Not accepted

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.).

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
OTHER	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).

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-11-01
• Completion: 2019-11-25
• First posted: 2020-08-11
• Last updated: 2020-08-17

Locations

1 site across 1 country: France