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OpenTrials
Completed

NCT Number: NCT00449891

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

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.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • William E And Aenid R Weisgerber Foundation

Registry information

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2007
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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