Vyvanse and Glucose Intolerance in Children With ADHD and Obesity
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.
研究概览
简要总结
The purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female, ages between 8 and 17
- •Body Mass Index > 30
- •fasting blood sugar between 90-100 mg/dl
- •2 hour post prandial >140 <180 mg/dl
- •meets criteria for a diagnosis of ADHD, any subtype
排除标准
- •known cardiovascular disease or diabetes
- •structural cardiac abnormalities, abnormal ECGs, family history of sudden death
- •positive urine drug screen
- •fasting blood sugar level > 126 mg/dl
- •HbA1c > 6.5 %
- •Weight > 300 lbs
研究组 & 干预措施
Open label Vyvanse
Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
干预措施: Lis-dexamphetamine (Drug)
结局指标
主要结局
Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.
时间窗: Baseline to end of study
The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.
次要结局
未报告次要终点