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NCT Number: NCT04508673

Impact of GH Measurements on GHD Diagnosis

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.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Disease Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34290, France

About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GH provocation tst

Other

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).

Other names: reliquens of serum samples from GH provocation test

Primary outcomes

  1. Comparative study of human growth hormone measurements

    Time frame: 1 day

    Comparative study of human growth hormone measurements by using three different automated immunoassays

Secondary outcomes

  1. Stratification of patients based on GH peak secretion

    Time frame: 1 day

    Stratification of patients based on GH peak secretion

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2020
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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