Ultrasound imaging to detect type 1 diabetes
Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes
This study is testing a new ultrasound method to see if it can help detect type 1 diabetes by measuring blood flow in the pancreas, comparing healthy people to those who have recently been diagnosed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05482321 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test a new ultrasound imaging method to detect type 1 diabetes by measuring blood flow in the pancreas. Researchers will establish a standard operating procedure for assessing pancreas blood flow speed and volume using a contrast agent. The study will compare these measurements between healthy individuals and those who have recently developed type 1 diabetes, while also evaluating variability in measurements over time. Participants will undergo ultrasound scans at the University of Colorado Hospital after providing informed consent.
Who should consider this trial
Good fit: Ideal candidates include males and non-pregnant females aged 18-65 who are willing to participate fully in the study.
Not a fit: Patients with excessive body size preventing effective scans or those with exocrine pancreatic diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of type 1 diabetes, allowing for timely intervention and management.
How similar studies have performed: While similar ultrasound imaging approaches have been explored, this specific method using contrast-enhanced ultrasound for type 1 diabetes detection is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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): Inclusion criteria: No additional inclusion criteria Exclusion criteria: * 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) Inclusion criteria: * 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 * Presence of insulin autoantibody will only be valid if taken within the first 14 days of diagnosis. * Diagnosis of diabetes within 180 days prior to participation in the study Exclusion criteria: * 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
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz, Barbara Davis Center — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Richard KP Benninger, PhD — University of Colorado, Denver
- Study coordinator: Morgan Sooy
- Email: morgan.sooy@cuanschutz.edu
- Phone: 303 724 7526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.