Validation of the Dosage of Asymmetric Dimethylarginine (ADMA) Plasma in the Assessment of Endothelial Dysfunction During Growth Hormone Deficiency and Intrauterine Growth Retardation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Plasma Asymmetric Dimethylarginine (ADMA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Plasma Asymmetric Dimethylarginine (ADMA)
时间窗: 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)
Percentage of dilation of the brachial artery at Doppler ultrasound examination.
时间窗: 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.
次要结局
- Difference of ADMA concentration between the patient and the control groups(At baseline)
- Correlation of ADMA levels with diverse cardiovascular risk factors(At baseline)