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Diabetic Ketoacidosis and Its Impact on the Brain

This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Collaborator:
The Weisgerber Foundation
Information provided by (Responsible Party):
Tandy Aye, Stanford University
ClinicalTrials.gov Identifier:
NCT01753934
First received: September 18, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Diabetic Ketoacidosis and Its Impact on Neurocognition

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   None Retained

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.


Estimated Enrollment: 120
Study Start Date: May 2011
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753934

Contacts
Contact: Tandy Aye, MD (650) 723-5791 taye@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Tandy Aye, MD     650-723-5791     taye@stanford.edu    
Principal Investigator: Tandy Aye MD            
Sponsors and Collaborators
Stanford University
The Weisgerber Foundation
Investigators
Principal Investigator: Tandy Aye MD Stanford University
  More Information

No publications provided

Responsible Party: Tandy Aye, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01753934     History of Changes
Other Study ID Numbers: SU-05102011-7713
Study First Received: September 18, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Ketoacidosis
Ketosis
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Acidosis
Acid-Base Imbalance
Diabetes Complications

ClinicalTrials.gov processed this record on May 16, 2013