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CompletedNCT03422081GAMMAUpdated Dec 16, 2025

Growth and Asymmetric diMethylArginine

An observational study in Growth Hormone Deficiency and Small-for-gestational Age, sponsored by University Hospital, Lille. Completed at 2 sites in France. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
23
Ages
3 Years to 18 Years
Sex
All
01

Study 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) 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.
02

Conditions studied

  • Growth Hormone Deficiency
  • Small-for-gestational Age

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Keywords

  • endothelial dysfunction
  • doppler ultrasound examination
  • nitric oxide
03

In context

Dwarfism, Pituitary

252 studies on the registry are indexed under Dwarfism, Pituitary; 30 are open to participants now.

This study's enrollment of 23 is below the median of 70 across 73 observational studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

pediatric patients with growth disorders and matched control children

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • signed by representative of the parental authority

Exclusion criteria

Exclusion Criteria:

  • 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
  • Precocious puberty
  • Non-replacing therapy by 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 or oral refusal by the child to participate to the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
23 participants (actual)
Patient registry
No

Groups and cohorts

  • growth hormone deficiency

    Diagnostic Test: arterial doppler ultrasound

  • small for gestational age

    Diagnostic Test: arterial doppler ultrasound

  • matched controls

    Diagnostic Test: arterial doppler ultrasound

Interventions

  • Diagnostic testarterial doppler ultrasound

    doppler ultrasound

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: At baseline

  2. 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.

    Time frame: At baseline.

Secondary outcomes

  1. Difference of ADMA concentration between the patient and the control groups

    Time frame: At baseline

  2. Correlation of ADMA levels with diverse cardiovascular risk factors

    Time frame: At baseline

07

Study locations

2 sites
  • Hôpital Jeanne de Flandre - CHRU de Lille
    Lille, France
  • CHU Purpan
    Toulouse, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2014 to primary completion in Dec 2018, 54 months.

Of 30 observational studies under Dwarfism, Pituitary, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 102. This study's 54 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2018
First posted
Feb 5, 2018
StartActual
Jun 2014
Primary completionActual
Dec 31, 2018
CompletionActual
Dec 31, 2018
Last update
Dec 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03422081
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Jun 2014
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Dec 16, 2025

Study contacts

Jacques Weill, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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