Diabetic Ketoacidosis and Its Impact on the Brain

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Stanford University
Sponsor:
Collaborator:
William E And Aenid R Weisgerber Foundation
Information provided by (Responsible Party):
Tandy Aye, Stanford University
ClinicalTrials.gov Identifier:
NCT01753934
First received: September 18, 2012
Last updated: June 10, 2014
Last verified: June 2014

September 18, 2012
June 10, 2014
May 2011
May 2020   (final data collection date for primary outcome measure)
Memory score on ImPACT testing [ Time Frame: 15 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01753934 on ClinicalTrials.gov Archive Site
White matter volume on MRI using diffusion tensor imaging [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Values will be calculated according to manuscript by Aye et al in Diabetes Care Sept 2012 electronically published ahead; available on line
Same as current
Not Provided
Not Provided
 
Diabetic Ketoacidosis and Its Impact on the Brain
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.

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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

There is no intervention. All subjects with DM and controls get neurocognitive testing and an MRI of the brain. We want to see if the scores are different but no changes in therapy will be done.

Non-Probability Sample

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. We will compare this to a control group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus.

Diabetes Mellitus
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
May 2020
May 2020   (final data collection date for primary outcome measure)

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).

Both
4 Years to 16 Years
Yes
Contact: Tandy Aye, MD (650) 723-5791 taye@stanford.edu
United States
 
NCT01753934
SU-05102011-7713
No
Tandy Aye, Stanford University
Stanford University
William E And Aenid R Weisgerber Foundation
Principal Investigator: Tandy Aye MD Stanford University
Stanford University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP