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

Stanford University

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT00449891

1102002-100-GHATW

IRB 97517

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

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).