Diabetic Ketoacidosis and Its Impact on the Brain
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 4 - 16 |
| Updated: | 4/21/2016 |
| Start Date: | May 2011 |
| End Date: | May 2020 |
| Contact: | Tandy Aye, MD |
| Email: | taye@stanford.edu |
| Phone: | (650) 723-5791 |
Diabetic Ketoacidosis and Its Impact on Neurocognition
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.
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.
Participant Schedule:
1. One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological
testing and to become familiar with the MRI scanner.
2. Subjects who need to become more familiar with the MRI scanning process will view a
video tape at home.
3. One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head
completed.
4. Subjects between 10 and 17 years of age will also be asked to complete two additional
abbreviated neuropsychological tests at one week and one month from enrollment.
5. Subjects may have the complete neuropsychological testing and MRI scan repeated 15
months from time of enrollment.
1. One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological
testing and to become familiar with the MRI scanner.
2. Subjects who need to become more familiar with the MRI scanning process will view a
video tape at home.
3. One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head
completed.
4. Subjects between 10 and 17 years of age will also be asked to complete two additional
abbreviated neuropsychological tests at one week and one month from enrollment.
5. Subjects may have the complete neuropsychological testing and MRI scan repeated 15
months from time of enrollment.
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).
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
Stanford, California 94305
(650) 725-3900
Principal Investigator: Tandy Aye MD
Phone: 650-723-5791
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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