Impact of GH Measurements on GHD Diagnosis

NCT04508673 | Completed

• 1 other identifier: RECHMPL20_0449
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Hormone Deficiency

Keywords

growth hormone deficiency; immunoanalysis; hGH provocation test; diagnosis

Outcome Measures

Primary Outcomes (1)

• Comparative study of human growth hormone measurements

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

  1 day

Secondary Outcomes (1)

• Stratification of patients based on GH peak secretion

  1 day

Interventions

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).

Also known as: reliquens of serum samples from GH provocation test

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

From April to November 2019, forty-one young patients (26 boys and 15 girls) from the Paediatric Department of Montpellier Hospital were included in this study. They were mainly admitted for suspicion (short stature or growth retardation) or follow-up of GHD in pre-and pubertal age (median age= 12).

You may qualify if:

• 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)

You may not qualify if:

• Age \> 18 years
• Patients undergoing different provocation tests

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34290, France

Location

Related Publications (1)

• 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.

  PMID: 34850616 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Dwarfism, Pituitary; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Manuela Lotierzo, PhD

  UH MONTPELLIER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: April 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 25, 2019
• Last Updated: August 17, 2020

Record last verified: 2020-08

Locations

FR (1)