Diabetic Ketoacidosis and Its Impact on the Brain

NCT ID: NCT01753934

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-10-31

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.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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).

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

William E And Aenid R Weisgerber Foundation

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Tandy Aye

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tandy Aye MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Aye T, Mazaika PK, Mauras N, Marzelli MJ, Shen H, Hershey T, Cato A, Weinzimer SA, White NH, Tsalikian E, Jo B, Reiss AL; Diabetes Research in Children Network (DirecNet) Study Group. Impact of Early Diabetic Ketoacidosis on the Developing Brain. Diabetes Care. 2019 Mar;42(3):443-449. doi: 10.2337/dc18-1405. Epub 2018 Dec 20.

Reference Type: RESULT

PMID: 30573652 (View on PubMed)

Other Identifiers

SU-05102011-7713

Identifier Type: -

Identifier Source: org_study_id