Stanford University School of Medicine
Stanford, California, 94305, United States
NCT Number: NCT01753934
About the Study: This research study is being conducted to see if diabetic ketoacidosis has any impact on learning, behavior and development in children with Type 1 diabetes mellitus. If there is an impact, is it transient or persistent? Sixty to 80 children between the ages of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a non-sedated MRI scan of the head performed. The investigators will compare this to a control group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood glucose values as required by your doctor and bring their meter(s) for downloading to each visit. The children with Type 1 diabetes mellitus should also tell your doctor about the frequency of severe low and high blood glucose values.
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Notify Me4 year–16 year
All sexes
Observational
Stanford, California, 94305, United States
Participant Schedule:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To take part in the study, the participant must meet the following inclusion criteria:
Exclusion criteria
If the interested participant has a history of head trauma with any loss of consciousness, 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).
Time frame: 15 months
The computerized electronic testing generates a standardized test score at the complete of the test. The scores will be compared from enrollment, one week, one month and at 3 months. The change in score from enrollment to one week with be the main number used for analysis
Time frame: 15 months
Values will be calculated according to manuscript by Aye et al in Diabetes Care Sept 2012 electronically published ahead; available on line
Stanford University
Other
Diabetic Ketoacidosis and Its Impact on Neurocognition
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