Two Arms, Open, Controlled, Prospective, Intervention Study to Evaluate the Growth and Metabolic Response to Growth Hormone and Gonadotropin-releasing Hormone Agonist Treatment Versus Growth Hormone Alone in Boys Born SGA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Height measurements
研究概览
简要总结
A 2-arms randomized open prospective intervention study to determine the Growth and metabolic response to growth hormone and gonadotropin-releasing hormone agonist treatment versus growth hormone alone in boys born SGA.
All subjects will be treated with NorditropinSimplex at a dosage of 100mcg/kg/d.
At onset of puberty, subjects will be randomized into either combined treatment with GH and GnRHa or GH alone.
详细描述
A 2-arms randomized open prospective intervention study including 20 boys, in order to determine the effect of growth hormone (GH) and gonadotropin-releasing hormone agonist treatment versus growth hormone (GnRHa) alone on growth and metabolic response.
Objectives:
The primary objective is to investigate the effect of delaying the pubertal process by pubertal suppression on growth and final height of boys who were born SGA and treated with GH.
The secondary objectives are to determine the metabolic effect of the combined therapy of GH plus gonadotropin agonists to that of GH alone on the dietary intake, serum leptin, ghrelin, IGF-1, lipid and lipoprotein concentrations prior to and during treatment, and to assess the quality of life between the two groups.
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •height of at list 2.0 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC)
- •Prepubertal (tanner stage 1) at commencement of trail
- •Peak GH above 10ng/ml in at least one provocative test for GH secretion 7.Signed informed consent
排除标准
- •Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
- •Treatment with any medical product which may interfere with GH effects
研究组 & 干预措施
1
GH & GNRHa treatment
干预措施: growth hormone and gonadotropin-releasing hormone agonist (Drug)
2
GH treatment
干预措施: growth hormone (Drug)
结局指标
主要结局
Height measurements
时间窗: every 3 monthes, during all study period
次要结局
- IGF-1 concentration(every 6 monthes, during all study period)
- Hormone profile, Lipid and lipoprotein concentrations(once a year during all study period)
- Prepubertal changes(every 3 monthes during all study peiod)
- Bone age(once a year, during all study period)
- quality of life questionnaire(once a year, during all study period)
- Psychological questionnaire(once a year, during all study peiod)