Clinical trial NCT03422081: Growth and Asymmetric diMethylArginine
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Growth Hormone Deficiency
Small-for-gestational Age
Keywords: endothelial dysfunction
doppler ultrasound examination
nitric oxide
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 23
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients with growth disorders and matched control children

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Asymmetric Dimethylarginine (ADMA)
timeFrame: At baseline
measure: Percentage of dilation of the brachial artery at Doppler ultrasound examination.
timeFrame: At baseline.
Secondary outcomes:
measure: Difference of ADMA concentration between the patient and the control groups
timeFrame: At baseline
measure: Correlation of ADMA levels with diverse cardiovascular risk factors
timeFrame: At baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandre - CHRU de Lille
city: Toulouse
country: France
facility: CHU Purpan
Study officials:
affiliation: University Hospital, Lille
name: Jacques Weill, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: