Growth and Asymmetric diMethylArginine (NCT03422081) | Clinical Trial Compass
CompletedNot Applicable
Growth and Asymmetric diMethylArginine
France23 participantsStarted 2014-06
Plain-language 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.
Who can participate
Age range
3 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Asymmetric Dimethylarginine (ADMA)
Timeframe: At baseline
2
Percentage of dilation of the brachial artery at Doppler ultrasound examination.