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| Name | Class |
|---|---|
| American College of Radiology | OTHER |
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The goal of the study is to characterize preclinical Alzheimer's Disease and related dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset diabetes, and an age-similar group of young adults without diabetes.
The goal of the current proof-of-concept study is to characterize brain structural, functional, and molecular imaging biomarkers of preclinical Alzheimer's Disease and related dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset diabetes (Y-DM; type 1 diabetes [T1D], n=5; type 2 diabetes [T2D], n=5) from the SEARCH for Diabetes in Youth study cohort, and an age-similar group of young adults without diabetes (n=5). This study will quantify structural and functional imaging biomarkers of AD/ADRD neuropathology via magnetic resonance imaging by assessing gray matter (GM) volume/cortical thickness, as well as GM and white matter (WM) microstructure, resting state functional network connectivity (rsfMRI), and cerebral blood flow (CBF) and WM hyperintensity volume. This study will additionally quantify brain tau density via positron emission tomography as the gold-standard measure of preclinical AD/ADRD neuropathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1D | Young adults with youth-onset type 1 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort |
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| T2D | Young adults with youth-onset type 2 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort |
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| NDM | Age-similar group of young adults without diabetes (n=5) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PI-2620 tracer | Drug | Following published manufacturer guidelines for Flutemetamol (VizamylTM), Flortaucipir (TauvidTM) and PI-2620 tracer administration162, all participants will be given a 370 MBq (10 mCi) single intravenous bolus (total volume 10mL) of the radiotracer, followed with an intravenous flush of 0.9% sodium chloride injection. Radiotracer administration and participant monitoring will be conducted by trained personnel from the CU-RIC. |
| Measure | Description | Time Frame |
|---|---|---|
| Temporal lobe volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR | Baseline |
| Temporal lobe cortical thickness in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR | Baseline |
| Whole brain white matter hyperintensities volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Structural cerebrovascular disease via Sagittal 3D FLAIR | Baseline |
| Regional homogeneity of the default mode network in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Resting-state functional connectivity via Axial T2* EPI fcMRI | Baseline |
| Whole brain cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Cerebral blood flow or perfusion via Axial 3D pCASL | Baseline |
| Whole brain fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Gray matter and white matter microstructure via Diffusion Kurtosis Imaging | Baseline |
| Standardized uptake value ratio for hippocampal to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes |
| Measure | Description | Time Frame |
|---|---|---|
| Whole brain gray matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR | Baseline |
| Whole brain white matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of young adults with youth-onset type 1 diabetes and type 2 diabetes from the SEARCH for Diabetes in Youth study cohort, and an age-similar group of young adults (18-40 years old) without diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Allison Shapiro, PhD, MPH | University of Colorado, Denver | Principal Investigator |
| Christopher T Whitlow, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifecourse Epidemiology of Adiposity and Diabetes Center | Aurora | Colorado | 80045 | United States |
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|
Tau accumulation via positron emission tomography with PI-2620 radiotracer |
| Baseline |
| Standardized uptake value ratio for entorhinal to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Tau accumulation via positron emission tomography with PI-2620 radiotracer | Baseline |
| Standardized uptake value ratio for cerebral to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Tau accumulation via positron emission tomography with PI-2620 radiotracer | Baseline |
Voxel-based morphometry via Sagittal 3D Accelerated MPRAGE/IRSPGR |
| Baseline |
| Perivascular space in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Structural cerebrovascular disease via Sagittal 3D FLAIR | Baseline |
| Atlas based region of interest cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Cerebral blood flow via Axial 3D pCASL | Baseline |
| Atlas based region of interest fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes | Gray matter and white matter microstructure via Diffusion Kurtosis Imaging | Baseline |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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