Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes (HYPO)
125 children with Type 1 Diabetes mellitis (T1DM) between 4 and 16 were recruited and 62 healthy siblings also enrolled in the study.
Children with T1DM and sibling controls ages 4 to 16 were assessed on memory and executive control skills at entry to the study (Test 1) and after two years of close monitoring for blood sugar events (Test 2). Diabetic children have their blood sugar tested directly before and after cognitive testing to ensure their blood sugar is within range during the testing. The 2-year follow-up period involves parents/child reporting any severe diabetic episode and periodically providing the results of the diabetic child's usual blood tests from their glucose monitoring device.
Children 7 and older also underwent high resolution MRI scans.
研究概览
地位
条件
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age 4 - 16 (for MRI, must be 7 or older)
Exclusion Criteria:
- Pregnant or lactating (females 13+)
- Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis. (Exclude for hypothyroidism)
- Other current serious medical illness
- Co-morbid psychiatric illness: such as mania, ADHD, LD, major depression, mental retardation, or psychoactive drug dependence
- Co-morbid neurological illness: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries (i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
- EXCEPT T1DM-related
- Pre-maturity at birth >4 wks early (<36 wk term) w/ sequelae e.g. on respirator at NICU
- Use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed) or pts. w/recent tx w/dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall
- Contraindication to MRI scan (e.g. claustrophobia, metal implants, foreign bodies) - N/A if < 4 years old
- Full set (top and bottom) orthodontic braces. (Half set braces, fillings, and retainers are OK)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Type 1 Diabetes Mellitis
Children with Type 1 Diabetes Mellitis (T1DM) between 4 and 16 were recruited.
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Non diabetic Control
62 healthy siblings also enrolled in the study between the ages of 4 and 17.
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合作者和调查者
调查人员
- 首席研究员:Tamara G Hershey, PhD.、Washington Univeristy School of Medicine
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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