Growth and Asymmetric diMethylArginine (GAMMA)

University Hospital, Lille

Status

Completed

Conditions

Growth Hormone Deficiency

Small-for-gestational Age

Treatments

Diagnostic Test: arterial doppler ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT03422081

2012_61

2013-A00830-45 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

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