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

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT00449891
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-21
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States