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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2016-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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).

Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes