Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Male or non-pregnant female age 18-65

• Ability and willingness of patient to participate fully in all aspects of this clinical study

• Written informed consent obtained and documented

Locations
United States
Colorado
University of Colorado Anschutz, Barbara Davis Center
RECRUITING
Aurora
Contact Information
Primary
Morgan Sooy
morgan.sooy@cuanschutz.edu
303 724 7526
Backup
Hali Broncucia
hali.broncucia@cuanschutz.edu
303 724 7526
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2025-09
Participants
Target number of participants: 50
Treatments
Group 1
SOP (healthy) subjects. Part I of study (optimizing protocol).
Group 2
Control (healthy and autoantibody positive) subjects. Part II of study (cross-sectional study)
Group 3
T1D subjects. Part II of study (cross-sectional study)
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov