Pancreas Ultrasound Imaging in type1 Diabetes

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05482321
Status
Recruiting
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Conditions

  • Insulitis
  • Pancreas Inflamed
  • Type1diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Definity Suspension for Injection — DRUG
    * DEFINITY is administered as per manufactures instructions * 1 vial of DEFINITY is allowed to warm to room temperature and activated by 45s shaking on a VIALMIX * Withdraw the activated milky white suspension using the provided Dispensing Pin, PINSYNC or 18-20 gauge syringe needle, from the middle of the liquid in the inverted vial. * Deliver a dose of 10 μl/kg of 'milky white suspension' IV as a bolus, delivered over 30seconds. * Following imaging, provide a 10 mL flush of preservative-free saline * Wait at least 30minutes until second dose (if provided).

Study Details

The overall goal of this study is to develop and test a novel method involving ultrasound imaging, in order to detect the development of type 1 diabetes. In this study the investigators will first establish a standard operating procedure for measuring pancreas blood flow speed and volume in the pancreas of human subjects. The investigators will then determine 1) whether these pancreas blood flow factors differ between healthy subjects and those who have recently developed type1 diabetes; and 2) how variable measurements are in healthy subjects and subjects that recently developed type1 diabetes, both between subjects and over time. To address these aims the investigators will perform pancreas ultrasound measurements in each subject using an approved injectable 'bubble' contrast agent that allows measurement of pancreas blood flow. The investigators will compare ultrasound measurement with characteristics of the subject's type 1 diabetes, including genetic factors, glucose levels and other circulating factors, as well as other factors that may influence blood flow in the pancreas independent of type1 diabetes. The successful conclusion of this study will indicate whether measuring pancreas blood flow speed/volume will be helpful in monitoring whether type1 diabetes will emerge and thus will allow a large scale study to answer this question.

Key Dates

Start date
Feb 27, 2023
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Group 1
    SOP (healthy) subjects. Part I of study (optimizing protocol).
  • Arm: Group 2
    Control (healthy and autoantibody positive) subjects. Part II of study (cross-sectional study)
  • Arm: Group 3
    T1D subjects. Part II of study (cross-sectional study)

Primary Outcome Measure

Primary outcome 1 [ Time Frame: End of part I (6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz, Barbara Davis CenterAuroraColorado80045
Hali C Broncucia, MA
[email protected]
303-724-7526
Morgan Sooy, MS
[email protected]
303-724-5686

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By research site
University of Colorado Anschutz, Barbara Davis Center· Aurora, CO

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