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Diabetes Mellitus, Type 1NCT05350514

Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study

An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
PI-2620 tracer
Type of treatment
Injection or infusion
How many people
14 participants
Where
1 siteUnited States
Study dates
19 Jul 2022to 31 May 2023
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lifecourse Epidemiology of Adiposity and Diabetes Center

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the 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.

Being tested
PI-2620 tracer
Keywords
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes, Youth Onset, Magnetic Resonance Imaging, Positron Emission Tomography Imaging
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PI-2620 tracerDrug

    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.

Study groups in NCT05350514
Study groupRoleWhat they receive
T1DYoung adults with youth-onset type 1 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort
Receives: Drug: PI-2620 tracer
T2DYoung adults with youth-onset type 2 diabetes (n=5) from the SEARCH for Diabetes in Youth study cohort
Receives: Drug: PI-2620 tracer
NDMAge-similar group of young adults without diabetes (n=5)
Receives: Drug: PI-2620 tracer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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

    Measured: Baseline

  3. 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

    Measured: Baseline

  4. 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

    Measured: Baseline

  5. 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

    Measured: Baseline

  6. 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

    Measured: Baseline

  7. Standardized uptake value ratio for hippocampal 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

    Measured: Baseline

  8. 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

    Measured: Baseline

  9. 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

    Measured: Baseline

Secondary outcomes (5)

  1. 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

    Measured: Baseline

  2. Whole brain white 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

    Measured: Baseline

  3. Perivascular space in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes

    Structural cerebrovascular disease via Sagittal 3D FLAIR

    Measured: Baseline

  4. 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

    Measured: Baseline

  5. 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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start19 Jul 2022
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
14 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05350514
Sponsor's protocol ID
22-0608
Status last verified
Nov 2023
First submitted
12 Apr 2022
Last updated
30 Nov 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temporal lobe volume in young adults with Type 1 diabetes, Type 2 diabetes, and young adults without diabetes (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05350514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.

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