Pancreas Ultrasound Imaging in type1 Diabetes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Colorado, Denver

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Excessive body size preventing effective scan of the pancreas as determined by sonographer

Evidence of exocrine pancreatic disease, including pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, or neuroendocrine tumor.

Subjects who are pregnant or breast-feeding

Subjects incapable of giving assent/informed written consent

Trial design

Treatments tested in this trial

  • Definity Suspension for Injection

Treatment groups

50 Participants
are divided into 3 treatment groups

Sponsors and collaborators