Clinical trial NCT05350514: Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study
Official title: Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes, Youth Onset
Keywords: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes, Youth Onset
Magnetic Resonance Imaging
Positron Emission Tomography Imaging
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American College of Radiology
First posted: 2022-04-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Part of the SEARCH for Diabetes in Youth study cohort or
* Age 18-40
* Without diabetes

Exclusion Criteria:

* Head trauma with loss of consciousness \>30 minutes
* Claustrophobia
* Metal in the body
* Major psychiatric disorder (eg. schizophrenia, bipolar, and major depression)
* Neurological conditions affecting cognition (eg. epilepsy)
* Stroke
* If female, breastfeeding, plan to become pregnant or are pregnant

Primary outcomes:
measure: Temporal lobe volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Temporal lobe cortical thickness in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Whole brain white matter hyperintensities volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Regional homogeneity of the default mode network in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Whole brain cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Whole brain fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Standardized uptake value ratio for hippocampal to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Standardized uptake value ratio for entorhinal to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Standardized uptake value ratio for cerebral to cerebellar comparison in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
Secondary outcomes:
measure: Whole brain gray matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Whole brain white matter volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Perivascular space in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Atlas based region of interest cerebral blood flow in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
measure: Atlas based region of interest fractional anisotropy in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Lifecourse Epidemiology of Adiposity and Diabetes Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Allison Shapiro, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Christopher T Whitlow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: