Brain Health and Development With T1DM (NewT)
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|ClinicalTrials.gov Identifier: NCT03335878|
Recruitment Status : Suspended (Due to COVID 19.)
First Posted : November 8, 2017
Last Update Posted : May 12, 2020
|Condition or disease|
|T1DM Brain Development|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Early Predictors of Brain Health and Development in Youth With T1DM|
|Actual Study Start Date :||September 1, 2016|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 2, 2021|
Type 1 Diabetes Mellitus Group
T1DM Group - 150 otherwise healthy children, ages 4-16 years old, diagnosed with T1DM within 3 months prior to their initial study visit. This is not a treatment study therefore there is no intervention in this study.
Healthy Control Sibling Group
Sibling Control Group - 50 age and gender matched healthy siblings without a diagnosis of T1DM. This is not a treatment study therefore there is no intervention in this study.
- Scaled score on Verbal IQ tests at 18 months [ Time Frame: 18 months ]The investigators hypothesize that age of onset and severity of presentation will interact to explain neuroimaging and cognitive outcomes at 3 months post-diagnosis. Specifically, the study investigators predict that patients with earlier age of onset and greater severity of clinical presentation (presence of DKA, greater HbA1c values at diagnosis) will have lower performance and more atypical brain structure and functional connectivity compared to older patients with less severe presentation and to age-matched controls, after controlling for gender, parental socioeconomic status (SES), parental IQ and intervening glycemic control. Primary neuroimaging outcomes are hippocampal volume and regional gray matter volume, microstructural white matter parameters and functional connectivity of the default mode network. Primary cognitive outcomes are memory and verbal intelligence.
- Functional Connectivity of the Default Mode Network at 18 months [ Time Frame: 18 months ]The study investigators hypothesize that the development of the brain between 3 and 21 months post-diagnosis will be differently affected by severity of clinical presentation and glycemic control during follow-up. Specifically, the study investigators predict that greater severity of clinical presentation will convey greater vulnerability to subsequent hyperglycemia and severe hypoglycemia. For example, those individuals with a severe clinical presentation and significant hyperglycemia post-diagnosis will have worse outcomes on the cognitive and neuroimaging variables identified in Aim 1.
- Hippocampal Volume at 18 months [ Time Frame: 18 months ]Retrospective studies suggest that lower β-cell function uniquely predicts future long-term complications such as retinopathy, above and beyond the effects of glycemic control and duration of disease. Thus, β-cell function also may be a physiologic mediator of brain outcomes. However, prospective studies have not been conducted in newly diagnosed T1DM youth to establish that this pattern holds for the brain. Study investigators hypothesize that patients with lower β-cell function (assessed through a mixed meal tolerance test, MMTT) will be more likely to have brain and cognitive differences (identified in Aim 1) compared to those with higher β-cell function, after controlling for age, gender, parental SES, parental IQ and glycemic control.
- White Matter Microstructure at 18 months [ Time Frame: 18 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335878
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Tamara G Hershey, PhD||Washington University Medical School|