NCT05482321 · University of Colorado, Denver
Pancreas Ultrasound Imaging in type1 Diabetes
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations