Skip to main content
OpenTrials
Completed

NCT Number: NCT01753934

Diabetic Ketoacidosis and Its Impact on the Brain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

Participant Schedule:

  • One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological testing and to become familiar with the MRI scanner.
  • Subjects who need to become more familiar with the MRI scanning process will view a video tape at home.
  • One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head completed.
  • 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.
  • Subjects may have the complete neuropsychological testing and MRI scan repeated 15 months from time of enrollment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To take part in the study, the participant must meet the following inclusion criteria:

  • Be between the ages of 4 to 17 years.
  • 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).

Treatment and study plan

Primary outcomes

  1. Memory score on ImPACT testing

    Time frame: 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 outcomes

  1. White matter volume on MRI using diffusion tensor imaging

    Time frame: 15 months

    Values will be calculated according to manuscript by Aye et al in Diabetes Care Sept 2012 electronically published ahead; available on line

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • William E And Aenid R Weisgerber Foundation

Registry information

Official study title

Diabetic Ketoacidosis and Its Impact on Neurocognition

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2012
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.