Metformin in Children With Motor Deficit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- insulin resistance
研究概览
简要总结
Obesity with insulin resistance in the paediatric population provides an increasing challenge. Children with neurological or neuromuscular diseases are even more prone to obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated with a decrease in physical fitness and a further increase in body fat. In this study we want to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese patients with neurological or neuromuscular diseases. Metformin is a well-established insulin sensitizer.
详细描述
Obesity with insulin resistance in the paediatric population provides an increasing challenge. Children with neurological or neuromuscular diseases are even more prone to obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated with a decrease in physical fitness and a further increase in body fat. In this study we want to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese patients with neurological or neuromuscular diseases. Metformin is a well-established insulin sensitizer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with neurogenic or myogenic motor deficit, clinically obese or who had excessively gained weight over the last year.
排除标准
- •Exclusion criteria were known type 1 or type 2 diabetes mellitus and contraindications to metformin therapy.
研究组 & 干预措施
B: Placebo during 6 months, afterwards 12 months metformin
Placebo during 6 months, afterwards 12 months metformin
干预措施: Placebo (Drug)
A: Metformin during 12 months and then 6 months Placebo
Metformin during 12 months and then 6 months Placebo
干预措施: Metformin (Drug)
B: Placebo during 6 months, afterwards 12 months metformin
Placebo during 6 months, afterwards 12 months metformin
干预措施: Metformin (Drug)
A: Metformin during 12 months and then 6 months Placebo
Metformin during 12 months and then 6 months Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
insulin resistance
时间窗: 12 months
changes in insulin, fasting glucose and insulin resistance after 6 months Metformine versus 6 months placebo
次要结局
- fat(12 months)