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Diabetic Ketoacidosis and Its Impact on the Brain
Not Recruiting
Trial ID: NCT01753934
Purpose
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.
Official Title
Diabetic Ketoacidosis and Its Impact on Neurocognition
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
To take part in the study, the participant must meet the following inclusion criteria:
1. Be between the ages of 4 to 17 years.
2. Either has been diagnosed with type 1 diabetes mellitus OR does not have type 1
diabetes mellitus
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).
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Tandy Aye, MD
650-723-5791