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

Stanford University30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes Mellitus

Eligibility

Sex: ALLMin age: 3 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Stanford University

Stanford, California, United States

Data from ClinicalTrials.gov

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