Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05482321

Pancreas Ultrasound Imaging in type1 Diabetes

Led by University of Colorado, Denver · Updated on 2026-05-06

50

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pancreas Ultrasound Imaging in type1 Diabetes

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or non-pregnant female aged 18 to 65 years
  • Ability and willingness to fully participate in all study aspects
  • Written informed consent obtained and documented
  • For control group: no diagnosis of diabetes as per ADA criteria
  • For type 1 diabetes group: diagnosis of diabetes within 180 days and presence of specific autoantibodies
  • Participants taking metformin must be willing to stop medication two weeks before scans
Not Eligible

You will not qualify if you...

  • Excessive body size preventing effective pancreas scan
  • Presence of exocrine pancreatic diseases like pancreatitis or pancreatic tumors
  • Pregnancy or breastfeeding
  • Inability to provide informed consent
  • Known or suspected allergy to perflutren
  • Unstable heart or lung conditions such as recent heart attack or serious arrhythmias
  • Use of certain diabetes medications except metformin (unless stopped two weeks prior)
  • Recent immunomodulatory treatment within 3 months before enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz, Barbara Davis Center

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

M

Morgan Sooy

CONTACT

H

Hali Broncucia

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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