Type1diabetes Clinical Trial
Official title:
Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes
NCT number | NCT05482321 |
Other study ID # | 19-1543 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 27, 2023 |
Est. completion date | September 2024 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Anschutz, Barbara Davis Center | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
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