Status:
COMPLETED
Brain Health and Development With T1DM
Lead Sponsor:
Washington University School of Medicine
Conditions:
T1DM
Brain Development
Eligibility:
All Genders
4-16 years
Brief Summary
Type 1 diabetes mellitus (T1DM) is typically diagnosed in childhood and over time can lead to complications affecting the retina, heart, kidneys, peripheral nerves, and more recently appreciated, the ...
Detailed Description
NewT study staff will work with inpatient diabetes nurses and clinical diabetes educators at St. Louis Children's Hospital to identify patients that are admitted for new onset T1DM. Once the patients ...
Eligibility Criteria
Inclusion
- T1DM Group
- Otherwise healthy children with T1DM
- Between the ages of 4 to 16 years old
- Must be able to lie still in the MRI for 60 minutes
Exclusion
- Mental retardation
- Enrollment in special education classes or receiving special services
- Major psychiatric (e.g. depression, autism) or neurological illnesses (e.g. head injury with loss of consciousness)
- Currently taking medications with known central nervous system effects (including those for ADHD)
- Physical limitations that would interfere with testing
- Contraindications for MRI scans
- Females who are pregnant and/or lactating will be excluded
- Chronic diseases in addition to T1DM other than well-controlled asthma, celiac disease or Hashimoto's thyroiditis as determined by their clinical endocrinologist and/or nurse
- Sibling Control Group
- Inclusion Criteria:
- Healthy sibling of a T1DM participant
- Matched with a T1DM participant for age and gender
- Between the ages of 4 to16 years old
- Must be able to lie still in the MRI for 60 minutes
- Exclusion Criteria
- Mental retardation
- Enrollment in special education classes or receiving special services
- Major psychiatric (e.g. depression, autism) or neurological illnesses (e.g. head injury with loss of consciousness)
- Currently taking medications with known central nervous system effects (including those for ADHD)
- Physical limitations that would interfere with testing
- Contraindications for MRI scans
- Females who are pregnant and/or lactating will be excluded
- Chronic diseases other than well-controlled asthma, celiac disease or Hashimoto's thyroiditis as determined by their clinical endocrinologist and/or nurse.
- The Parent population will consist of one biological parent for each minor participant. The proxy participant will complete two neuropsychological tests as well as answer questionnaires about the minor study participant. The parent population has no age limitations but must be a biological parent to the minor study participant. The testing takes approximately 20 minutes thus the parent population will not be paid for their participation.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2021
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT03335878
Start Date
September 1 2016
End Date
December 6 2021
Last Update
April 11 2024
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110