Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their MRI scan.
详细描述
In this pilot study approximately 10-20 children between the ages of 3 to 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed every three years for three years. We will compare this to a control group of 10 children between the ages of 3 adn 10 years without Type 1 diabetes mellitus. The control subjects will neuropsychological testing and a nonsedated MRI scan of the head once. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for study subjects:
- •To be between ages 3 to 10 years
- •Have been diagnosed with type 1 diabetes for at least 6 months; and
- •Do not have plans to move out of the area within the next 36 months.
- •Inclusion Criteria for control subjects:
- •To be between ages 3 to 10 years
排除标准
- •No history of head trauma with any loss of consciousness,
- •Cystic fibrosis,
- •Prematurity (born less than 30 weeks of gestation),
- •Significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age),
- •Neurologic disease independent of diabetes (eg seizure disorder); or
- •Medical contraindication to MRI procedure (eg metal appliances such as braces).
研究者
Tandy Aye
Assistant Professor
Stanford University