Growth Hormone DeficiencyGAMMANCT03422081
Growth and Asymmetric diMethylArginine
An observational study of Growth Hormone Deficiency and Small-for-gestational Age, run by University Hospital, Lille at 2 sites in France.
Trial summary
Principal objective : Validation of a handy biochemical parameter, plasma concentration of Asymmetric DimethylArginine (ADMA), based on a recognize biochemical parameter, the dilation of the brachial artery, at ultrasound examination, after the deflation of a cushion to evaluate artery dysfunction (vascular suffering)… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Growth Hormone Deficiency, Small-for-gestational Age
- What is being tested?
- arterial doppler ultrasound
- How many people
- 23 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2014to 31 Dec 2018
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients with growth disorders and matched control children
Who may be able to join
- Group A: GHD, defined by 2 GH peaks less than 6.6 ng/ml (20 mU/L) at two stimulation tests
- Group B: IUGR, defined by a birth length and/or a birth weight inferior to - 2 SD for gestational age according to Usher and McLean charts
- Group C: Control children matched to children matched to subjects of groups A and B, according to gender and age
- Informed consent signed by representative of the parental authority
Who cannot join
- Chronic disabling disease (ex: diabetes, severe asthma)
- Evolving cancer
- Severe psychiatric disorder (ex: autism, schizophrenia; severe depression)
- Hypothalamic tumor (ex: craniopharyngioma)
- Anamnesis of cranial irradiation
- Overweight, obesity or thinness
Show all 15Show fewer
- Precocious puberty
- Non-replacing therapy by glucocorticoids or sex steroids less than 1 month before the exploration
- Anterior treatment by recombinant human GH
- Other conditions, treatments or habits impacting arterial reactivity: acrocyanosis, cryoglobulinemia, beta adrenergic blocking habits, tobacco smoking or other drug addictions, dyslipidemia
- Pregnancy or lactation
- Acute infection less than three weeks before the investigation
- Participation to a therapeutic protocol
- Impossibility for the representatives of the parental authority to understand the objectives of the protocol
- Absence of social security coverage. Refusal by the parents to sign the informed consent or oral refusal by the child to participate to the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Jeanne de Flandre - CHRU de Lille
Lille
CHU Purpan
Toulouse
About this study
Official title: Validation of the Dosage of Asymmetric Dimethylarginine (ADMA) Plasma in the Assessment of Endothelial Dysfunction During Growth Hormone Deficiency and Intrauterine Growth Retardation
Principal objective : Validation of a handy biochemical parameter, plasma concentration of Asymmetric DimethylArginine (ADMA), based on a recognize biochemical parameter, the dilation of the brachial artery, at ultrasound examination, after the deflation of a cushion to evaluate artery dysfunction (vascular suffering) in growth diseases, growth hormone deficiency (GHD) and intrauterine growth retardation (IUGR)
Secondary objectives:
- Comparison of ADMA plasma concentrations with dose of matched healthy control children
- Investigation of the mechanisms of arterial dysfunction, inflammation, oxidative stress and insulin resistance.
- Being tested
- arterial doppler ultrasound
- Keywords
- endothelial dysfunction, doppler ultrasound examination, nitric oxide
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial doppler ultrasoundDiagnostic test
doppler ultrasound
| Study group | Role | What they receive |
|---|---|---|
| growth hormone deficiency | Not described Receives: Diagnostic Test: arterial doppler ultrasound | |
| small for gestational age | Not described Receives: Diagnostic Test: arterial doppler ultrasound | |
| matched controls | Not described Receives: Diagnostic Test: arterial doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Asymmetric Dimethylarginine (ADMA)
Correlation between ADMA (Asymmetric DimethylArginine, a collateral derivate of nitric oxide metabolism) levels and the percentage of dilation of the brachial artery at Doppler ultrasound examination.
The dosage will be performed by high pressure liquid chromatography followed by tandem mass spectrometry (HPLC-MS / MS)
Measured: At baseline
Percentage of dilation of the brachial artery at Doppler ultrasound examination.
Correlation between ADMA (Asymmetric DimethylArginine, a collateral derivate of nitric oxide metabolism) levels and the percentage of dilation of the brachial artery at Doppler ultrasound examination.
Measured: At baseline.
Secondary outcomes (2)
Difference of ADMA concentration between the patient and the control groups
Measured: At baseline
Correlation of ADMA levels with diverse cardiovascular risk factors
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startJun 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Weill, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422081
- Sponsor's protocol ID
- 2012_61
- Other IDs
- 2013-A00830-45
- Acronym
- GAMMA
- Status last verified
- Dec 2025
- First submitted
- 10 Jan 2018
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Dosage of Asymmetric Dimethylarginine (ADMA) Plasma in the Assessment of Endothelial Dysfunction During Growth Hormone Deficiency and Intrauterine Growth Retardation
- ClinicalTrials.gov ID
- NCT03422081
- Acronym / sponsor ID
- GAMMA / 2012_61
- Keywords
- endothelial dysfunction, doppler ultrasound examination, nitric oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Feb 2018 (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.
Principal objective : Validation of a handy biochemical parameter, plasma concentration of Asymmetric DimethylArginine (ADMA), based on a recognize biochemical parameter, the dilation of the brachial artery, at ultrasound examination, after the deflation of a cushion to evaluate artery dysfunction (vascular suffering) in growth diseases, growth hormone deficiency (GHD) and intrauterine growth retardation (IUGR)
Secondary objectives:
- Comparison of ADMA plasma concentrations with dose of matched healthy control children
- Investigation of the mechanisms of arterial dysfunction, inflammation, oxidative stress and insulin resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| growth hormone deficiency | – | Diagnostic Test: arterial doppler ultrasound |
| small for gestational age | – | Diagnostic Test: arterial doppler ultrasound |
| matched controls | – | Diagnostic Test: arterial doppler ultrasound |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients with growth disorders and matched control children
Key inclusion criteria (4 listed)
- Group A: GHD, defined by 2 GH peaks less than 6.6 ng/ml (20 mU/L) at two stimulation tests
- Group B: IUGR, defined by a birth length and/or a birth weight inferior to - 2 SD for gestational age according to Usher and McLean charts
- Group C: Control children matched to children matched to subjects of groups A and B, according to gender and age
- Informed consent signed by representative of the parental authority
Key exclusion criteria (15 listed)
- Chronic disabling disease (ex: diabetes, severe asthma)
- Evolving cancer
- Severe psychiatric disorder (ex: autism, schizophrenia; severe depression)
- Hypothalamic tumor (ex: craniopharyngioma)
- Anamnesis of cranial irradiation
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 |
|---|---|---|
| arterial doppler ultrasounddoppler ultrasound | Diagnostic test | growth hormone deficiency, matched controls, small for gestational age |
Primary outcome
Plasma Asymmetric Dimethylarginine (ADMA)
Time frame: At baseline
Correlation between ADMA (Asymmetric DimethylArginine, a collateral derivate of nitric oxide metabolism) levels and the percentage of dilation of the brachial artery at Doppler ultrasound examination. The dosage will be performed by high pressure liquid chromatography followed by tandem mass spectrometry (HPLC-MS / MS)
Percentage of dilation of the brachial artery at Doppler ultrasound examination.
Time frame: At baseline.
Correlation between ADMA (Asymmetric DimethylArginine, a collateral derivate of nitric oxide metabolism) levels and the percentage of dilation of the brachial artery at Doppler ultrasound examination.
2 secondary outcomes
Difference of ADMA concentration between the patient and the control groups
Time frame: At baseline
Correlation of ADMA levels with diverse cardiovascular risk factors
Time frame: At baseline
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 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Jacques Weill, MD, PhD principal investigator
University Hospital, Lille
2 sites 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 and Small-for-gestational Age, run by University Hospital, Lille at 2 sites 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 4 inclusion and 15 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Plasma Asymmetric Dimethylarginine (ADMA) (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2025.