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Pancreas Ultrasound Imaging in type1 Diabetes

Sponsored by University of Colorado, Denver

About this trial

Last updated 3 years ago

Study ID

19-1543

Status

Not yet recruiting

Type

Observational [Patient Registry]

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Trial Timing

Ended a year ago

What is this trial 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 type1 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 type1 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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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

No

Exclusion Criteria

- BMI>30 (or excessive body size preventing effective scan of the pancreas)

- 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

- Known or suspected hypersensitivity to perflutren

- Known history or suspected unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)