NCT00306683已完成3 期
Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Relative weight change over two months
研究概览
简要总结
In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas
详细描述
Approximately 80 % of the hypothalamic-pituitary lesions that occur in children are craniopharyngiomas with one or three cases per 1 million children each year.
One major problem remains unsolved : the obesity
This study is performed to optimize the management of the children with hypothalamic-pituitary lesions by reducing the hyperinsulinemia due to the lesion and the surgery
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 18 years
- •Obesity with body mass index > 97 percentile or > 2 SD
- •Hypothalamic-pituitary lesions not evolutive
- •Hyperinsulinemia defined by insulin peak after oral glucose tolerance test>100 UI/L
- •Absence of diabetes mellitus defined by basal plasma glucose < 1.2 g/L and glucose peak after oral glucose tolerance test < 2 g/L and HbA1c < 7 %
- •Hormonal replacement therapy stable from at least three months excluding the treatment of diabetes insipidus which can be adjusted
- •Normal plasma thyroxine
- •Written informed consent of the children and the parents
排除标准
- •evolutive lesion
- •recent surgery or radiotherapy (< 6 months)
- •modification of hormonal replacement therapy during the three previous months
- •diabetes mellitus defined by basal plasma glucose > 1.2 g/L and glucose peak after oral glucose tolerance test > 2 g/L and HbA1c > 7 %
- •renal or hepatic failure
- •uncontrolled hypertension
- •hypersensitivity to benzothiazine drugs
- •pregnancy
- •difficulties to understand the protocol
结局指标
主要结局
Relative weight change over two months
时间窗: 2 months
Relative weight change over two months
(Weight at Day 1 - Weight at Day 60)/Weight at Day 1
次要结局
- Absolute weight change over two months
- Decrease of hyperinsulinemia
- Decrease of the glucose peak after oral glucose tolerance test (OGTT)
- Evolution of HbA1c
研究者
研究点 (2)
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