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Completed

NCT Number: NCT03422081

Growth and Asymmetric diMethylArginine

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.

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Jeanne de Flandre - CHRU de Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arterial doppler ultrasound

Diagnostic Test

doppler ultrasound

Primary outcomes

  1. 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)

  2. 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.

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: GAMMA

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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