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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449891
• Other study ID #: IRB 97517
• Secondary ID: 1102002-100-GHAT
• Status: Completed
• Phase: N/A
• First received: March 19, 2007
• Last updated: April 13, 2016
• Start date: January 2007
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	William E And Aenid R Weisgerber Foundation

Country where clinical trial is conducted

United States, 

External Links

•   Stanford University Division of Pediatric Endocrinology website