Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes
University of Colorado, Denver
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.
Description
Study Design and Research Methods Part I: 5 subjects from SOP group Goal: Optimize settings for destruction-replenishment contrast-enhanced ultrasound scan 1. Subject recruited at the Barbara Davis Center 2. Subject provides written consent 3. Review medical history (exclusion if required) 4. Subject refrains from eating for \~6h prior to measurement 5. Subject visits University of Colorado Hospital CTRC echo lab 6. CTRC staff places peripheral intravenous line (PIV) 7. Research staff collects vital signs, height and weight 8. Subject received conventional ultrasound scan to locate pancreas…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
All Participants: 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 Exclusion Criteria: * 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 * Known or su…
Interventions
- DrugDefinity Suspension for Injection
* 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).
Location
- University of Colorado Anschutz, Barbara Davis CenterAurora, Colorado