Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-12 @ 8:16 AM
Study NCT ID:
NCT01753934
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2012-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetic Ketoacidosis and Its Impact on the Brain
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Diabetic Ketoacidosis and Its Impact on Neurocognition
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: