Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH) by Comparison of Two Regimens of rhGH Administration to SGA Children. Pharmacogenetics of Metabolic Responses to rhGH
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA
研究概览
简要总结
Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.
详细描述
Recombinant growth hormone (rhGH) treatment is widely used in France to normalize height during childhood and final height in children born small for gestational age (SGA). Because rhGH has been associated with increased insulin levels and insulin resistance, concern has been expressed regarding the late consequences of rhGH treatment on risk factors for diabetes mellitus type II and metabolic syndrome, especially in possibly predisposed subjects as SGA children.
Because rhGH use in this population will sharply increase in the coming years, our purpose is to identify and analyze factors that predispose these children born SGA to the metabolic consequences of rhGH therapy.
The main objective of this study is to identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA. We want to:
- Quantify the metabolic effects of rhGH treatment by analyzing insulin levels, insulin sensitivity and lipid profile (lipolysis and ketogenesis);
- Evaluate the effects of two different rhGH regimens on the growth of children born SGA;
- Determine if the metabolic effects of rhGH therapy correlate to the growth responses in the two groups;
- Identify factors, especially genetic factors, responsible for the variations in individual metabolic and growth-promoting effects of rhGH in children born SGA.
This is a randomized, open-labeled, 2-year study, which will compare two regimens of rhGH therapy on the growth responses and metabolic effects in short children born SGA.
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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prepubertal age
- •Prepubertal characteristics
- •Non GH deficient
- •Short children (height < -2.5 SDS)
- •Born SGA (birth height < -2 SDS)
- •Parental height adjusted (< -1 DS)
- •No rhGH treatment before inclusion
排除标准
- •ALLERY to rhGH or excipients
- •Small height etiologies
- •Cancer or cancer treatment ongoing
- •Drugs interference with growth
- •Mental impairment
- •Hypertrophic cardiopathy impairment
- •Hypertension not under controlled
- •Intra cranial hypertension not controlled
- •Diabetes and hyperglycaemia without diabetes
- •Dyslipidemia
- •Hepatitis
- •Kidney failure
- •Chromosomic aberration and/or genetic disorders (except Silver Russel Syndrome)
- •No social security
- •State of health in worst conditions after cardiac surgery, polytraumatism
研究组 & 干预措施
1
the recommended dose in the EU of rhGH (Norditropine SimpleXx®)
干预措施: rhGH (Norditropine SimpleXx®) (Drug)
2
the dose to achieve a "treat-to target" value of IGF-1 levels within a +1.5 to +2.5 SDS interval (starting dose, 0.067 mg/kg/day)
干预措施: rhGH norditropine simple Xx (Drug)
结局指标
主要结局
Identify and analyze factors implicated in the variability of the metabolic and growth responses to rhGH treatment in children born SGA
时间窗: every three months during twenty seven months
次要结局
- Metabolic effects of rhGH treatment will be evaluated by body mass index (BMI)(every three months during)
- Polymorphisms of different genes of the signaling pathway of GH and insulin(the day of inclusion)