Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 1
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Tandy Aye
Assistant Professor
Stanford University
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified