Diabetic Ketoacidosis and Its Impact on the Brain

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT01753934
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-20
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Memory score on ImPACT testing	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

Secondary Outcome Measures

Name	Time	Method
White matter volume on MRI using diffusion tensor imaging	15 months	Values will be calculated according to manuscript by Aye et al in Diabetes Care Sept 2012 electronically published ahead; available on line

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States