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Clinical Trial Details

Trial ID: L4707
Source ID: NCT05482321
Associated Drug: Definity Suspension For Injection
Title: Pancreas Ultrasound Imaging in type1 Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type1diabetes|Insulitis|Pancreas Inflamed
Interventions: DRUG: Definity Suspension for Injection
Outcome Measures: Primary: 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: 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)., End of part II (1 year)|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)., End of part II (1 year)|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)., End of part II (1 year)|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)., End of part II (1 year)|Secondary outcome 5, Comparison of pancreas blood flow kinetics with subject BMI, age, heart rate, blood pressure (to test for a link between the measurement and subject characteristics), End of part II (1 year)|Secondary outcome 6, Assessment of subject autoantibodies, c-peptide levels (to ensure subjects free of diabetes do not have islet autoimmunity and to ensure subjects with T1D have islet autoimmunity and residual beta cell mass), End of part II (1 year)
Sponsor/Collaborators: Sponsor: University of Colorado, Denver
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 50
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2023-02-27
Completion Date: 2025-09
Results First Posted:
Last Update Posted: 2024-10-01
Locations: University of Colorado Anschutz, Barbara Davis Center, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT05482321