Pancreas Ultrasound Imaging in type1 Diabetes
Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
May 6, 2026
May 1, 2026
3.5 years
July 28, 2022
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Primary outcome 1
Optimized a contrast-enhanced ultrasound 'destruction-replenishment' protocol for imaging pancreas blood flow kinetics in adult human subjects.
End of part I (6 months)
Primary outcome 2
Comparison of pancreas blood flow kinetics (i.e. 'destruction-replenishment' k2 'reperfusion rate' parameter) between control and T1D subjects.
End of part II (1 year)
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
End of part II (1 year)
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.
End of part II (1 year)
Secondary Outcomes (6)
Secondary outcome 1
End of part II (1 year)
Secondary outcome 2
End of part II (1 year)
Secondary outcome 3
End of part II (1 year)
Secondary outcome 4
End of part II (1 year)
Secondary outcome 5
End of part II (1 year)
- +1 more secondary outcomes
Study Arms (3)
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)
Interventions
* 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).
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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 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)
- Group 2 (control subjects, part II):
- Diagnosis of diabetes according to the ADA recommended criteria (blood glucose and HbA1c will be measured)
- Use of medications used to control high blood sugar (GLP1R agonists, metformin\*, sulfonylureas)
- \*Participants taking metformin will be considered eligible if they are willing/able to stop taking the medication for at least two weeks prior to each scan.
- Any person who has received immunomodulatory intervention within 3 months of enrollment
- Group 3 (T1D subjects, part II)
- Diagnosis of diabetes according to the ADA recommended criteria (blood glucose and HbA1c will be measured)
- Evidence of autoantibodies to at least 1 of the following β-cell autoantigens:
- insulin, IA-2, GAD65, ZnT8
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz, Barbara Davis Center
Aurora, Colorado, 80045, United States
Biospecimen
Blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard KP Benninger, PhD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2022
First Posted
August 1, 2022
Study Start
February 27, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share