Growth Hormone DeficiencyNCT04508673
Impact of GH Measurements on GHD Diagnosis
An observational study of Growth Hormone Deficiency, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- GH provocation tst
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 25 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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)
Who cannot join
- Age > 18 years
- Patients undergoing different provocation tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Human Growth Hormone Measurements: Impact on Clinical Interpretation
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.
Read the 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
- Being tested
- GH provocation tst
- Keywords
- growth hormone deficiency, immunoanalysis, hGH provocation test, diagnosis
- Medical subject headings
- Dwarfism, Pituitary, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GH provocation tstOther
Also called reliquens of serum samples from GH provocation test
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative study of human growth hormone measurements
Comparative study of human growth hormone measurements by using three different automated immunoassays
Measured: 1 day
Secondary outcomes (1)
Stratification of patients based on GH peak secretion
Stratification of patients based on GH peak secretion
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Apr 2019
- Primary completion1 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuela Lotierzo, PhD, Principal investigator, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508673
- Sponsor's protocol ID
- RECHMPL20_0449
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
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.
PubMed 34850616
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Human Growth Hormone Measurements: Impact on Clinical Interpretation
- ClinicalTrials.gov ID
- NCT04508673
- Acronym / sponsor ID
- RECHMPL20_0449
- Conditions
- Growth Hormone Deficiency
- Keywords
- growth hormone deficiency, immunoanalysis, hGH provocation test, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Age > 18 years
- Patients undergoing different provocation tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GH provocation tstAlso: reliquens of serum samples from GH provocation testAll 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 | – |
Primary outcome
Comparative study of human growth hormone measurements
Time frame: 1 day
Comparative study of human growth hormone measurements by using three different automated immunoassays
1 secondary outcome
Stratification of patients based on GH peak secretion
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Derived from this study: PubMed 34850616Lotierzo 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.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuela Lotierzo, PhD principal investigator
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative study of human growth hormone measurements (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04508673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.