Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:3 - 10
Updated:4/21/2016
Start Date:January 2007
End Date:March 2016

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This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning,
behavior and development in young children and whether there are associated changes on their
MRI scan.

In this pilot study approximately 10-20 children between the ages of 3 to 10 years with Type
1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the
head performed every three years for three years. We will compare this to a control group of
10 children between the ages of 3 adn 10 years without Type 1 diabetes mellitus. The control
subjects will neuropsychological testing and a nonsedated MRI scan of the head once. The
children with Type 1 diabetes mellitus will not have any changes made to their current
diabetes regimen.

Inclusion Criteria:

Inclusion Criteria for study subjects:

- To be between ages 3 to 10 years

- Have been diagnosed with type 1 diabetes for at least 6 months; and

- Do not have plans to move out of the area within the next 36 months.

Inclusion Criteria for control subjects:

- To be between ages 3 to 10 years

Exclusion Criteria:

- No 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).
We found this trial at
1
site
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
2100
mi
from 43215
Stanford, CA
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