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
This trial accepts healthy volunteersQualifiers
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 population
Group 1 subjects will be healthy subjects who will receive contrast-enhanced ultrasound 'destruction-replenishment' measurements, in order to optimize and establish the standard operating procedure (SOP) for this measurement in the pancreas of human subjects. This SOP will then be applied to Group 2 (healthy subjects and autoantibody positive subjects) and Group 3 (recent onset type1 diabetes) subjects as part of the cross-sectional study. Classification of type 1 diabetes includes meeting ADA criteria for diabetes, within 180 days of diagnosis, and evidence of at least 1 islet-associated autoantibody.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Definity Suspension for Injection
Drug* 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).
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention
Trial outcomes
Primary outcomes
1
Primary outcome 1
Optimized a contrast-enhanced ultrasound 'destruction-replenishment' protocol for imaging pancreas blood flow kinetics in adult human subjects.
Time frame
End of part I (6 months)2
Primary outcome 2
Comparison of pancreas blood flow kinetics (i.e. 'destruction-replenishment' k2 'reperfusion rate' parameter) between control and T1D subjects.
Time frame
End of part II (1 year)3
Primary outcome 3
Determining inter-subject variability in pancreas blood flow kinetics (i.e. the 'destruction-replenishment' k2 'reperfusion rate' parameter) among control subjects and among T1D subjects
Time frame
End of part II (1 year)4
Primary outcome 4
Determining reproducibility in the measurement of pancreas blood flow kinetics (i.e. the 'destruction-replenishment' k2 'reperfusion rate' parameter) within subjects. This will initially focus on short-term intra-subject measurement variability.
Time frame
End of part II (1 year)Secondary outcomes
1
Secondary outcome 1
Comparison between control and T1D subjects for other parameters resulting from the measurement of pancreas blood flow kinetics (i.e. the 'destruction-replenishment' 'reperfusion amplitude' A, 'destruction efficiency' 1-B and 'pre-destruction signal' parameters).
Time frame
End of part II (1 year)2
Secondary outcome 2
Determining inter-subject variability among control subjects and among T1D subjects for other parameters resulting from the measurement of pancreas blood flow kinetics (i.e. the 'destruction-replenishment' 'reperfusion amplitude' A, 'destruction efficiency' 1-B and 'pre-destruction signal' parameters).
Time frame
End of part II (1 year)3
Secondary outcome 3
Correlation of pancreas blood flow kinetics with blood glucose and HbA1c (to test for a link between the measurement and glucose control).
Time frame
End of part II (1 year)4
Secondary outcome 4
Comparison of pancreas blood flow kinetics with HLA haplotype or whether subject has first-degree relative with T1D (to test for a link between the measurement and T1D genetic risk).
Time frame
End of part II (1 year)Sponsors and contacts
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Source ClinicalTrials.gov