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Growth and Asymmetric diMethylArginine

Validation of the Dosage of Asymmetric Dimethylarginine (ADMA) Plasma in the Assessment of Endothelial Dysfunction During Growth Hormone Deficiency and Intrauterine Growth Retardation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03422081
Acronym
GAMMA
Enrollment
23
Registered
2018-02-05
Start date
2014-06-30
Completion date
2018-12-31
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency, Small-for-gestational Age

Keywords

endothelial dysfunction, doppler ultrasound examination, nitric oxide

Brief 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.

Interventions

DIAGNOSTIC_TESTarterial doppler ultrasound

doppler ultrasound

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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 * Informed consent signed by representative of the parental authority

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 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

Design outcomes

Primary

MeasureTime frameDescription
Plasma Asymmetric Dimethylarginine (ADMA)At baselineCorrelation 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.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.

Secondary

MeasureTime frame
Difference of ADMA concentration between the patient and the control groupsAt baseline
Correlation of ADMA levels with diverse cardiovascular risk factorsAt baseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026