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The Effects of High and Low Blood Glucose Values on the Brain in Children With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690481
First Posted: September 21, 2012
Last Update Posted: April 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
William E And Aenid R Weisgerber Foundation
Information provided by (Responsible Party):
Tandy Aye, Stanford University
August 6, 2012
September 21, 2012
April 14, 2016
December 2006
December 2015   (Final data collection date for primary outcome measure)
MRI brain volumes [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT01690481 on ClinicalTrials.gov Archive Site
Neuropsychological scores [ Time Frame: 3 yr ]
FSIQ, Memory score, Verbal comprehension score
Same as current
Not Provided
Not Provided
 
The Effects of High and Low Blood Glucose Values on the Brain in Children With Type 1 Diabetes Mellitus
Neurocognitive and Neuroanatomical Studies in Young Children With Type 1 Diabetes Mellitus

Simplified Brochure

Neuropsychological Testing/Assessment is like games for the child. They are asked to complete the sequence, identify pictures, explain what is happening, etc. There is no personality testing involved. Part of the standard IQ testing is done but no IQ score is obtained. Age appropriate testing is done for each child.

The MRI is an enclosed machine. We have the child sit in a simulator after the neuropsychological testing to see what it will be like, including the sounds, etc. You will be given a video about MRI testing to view as well. The staff that does this has been doing this for years in a wide variety of children, young, developmental delayed, etc. The staff does this WITHOUT sedation. Some children cannot sit still through the entire series. We need to get six, 10 minute scans. Children are allowed movement such as the need to wiggle their toes and move in between each scan.

The Neuropsychological Testing can be scheduled in the late afternoons if it is more convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked to repeat the Neuropsychological Testing and MRI scanning 24 months later.

BROCHURE:

Name of Study: Neuropsychological and Neuroanatomical Studies in Young Children Study Directors: Tandy Aye, MD; Bruce Buckingham, MD; Darrell Wilson, MD

About the Study: This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children. Fifty to 60 children between the ages of 3 to less than 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed. The study will compare the results from those with diabetes to a control group of 20-30 children between the ages of 3 to less than 10 years without Type 1 diabetes mellitus. The control subjects will have neuropsychological testing and a nonsedated MRI scan of the head performed as well. All subjects maybe asked to repeat the neuropsychological testing and nonsedated MRI scan of the head 24 months later. 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 their doctors and bring their meter(s) for downloading to each visit. The child should also tell his/her doctor about the frequency of severe low and high blood glucose values to his/er doctor as routinely asked.

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 may have the neuropsychological testing and MRI scan repeated 24 months from time of the initial testing and scan.

Inclusion Criteria:

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

  1. Be between the ages of 3 to 10 years.
  2. Have been diagnosed with type 1 diabetes for at least 6 months.
  3. Do not have plans to move out of the area within the next 36 months.

Exclusion Criteria:

A history of head trauma with any loss of consciousness cystic fibrosis 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).

Compensation: There will be no cost to the subjects to participate in this research study. Participants will be compensated for their time. If you are interested in participating in this study and you meet the inclusion criteria, please contact:

Kim Caswell, APRN, BC (650)-724-1201 Email: kcaswell@stanford.edu Tandy Aye, MD (650)-723-5791 Email: taye@stanford.edu

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Children between ages 3 to 10 with and 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.
 
Completed
43
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • To take part in the study, you or your child must meet the following inclusion criteria:

    • Be between the ages of 3 to 10 years.
    • Have been diagnosed with type 1 diabetes for at least 6 months.
    • Do not have plans to move out of the area within the next 36 months.

Exclusion Criteria:

If the interested participant has a history of:

  • head trauma with any loss of consciousness,
  • cystic fibrosis,
  • 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)
Sexes Eligible for Study: All
3 Years to 10 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01690481
SU-09242009-4020
IRB# 7723
No
Not Provided
Not Provided
Tandy Aye, Stanford University
Stanford University
William E And Aenid R Weisgerber Foundation
Principal Investigator: Tandy Aye MD Stanford University
Stanford University
April 2016