Type1diabetesNCT05482321
Pancreas Ultrasound Imaging in type1 Diabetes
An observational study of Type1diabetes and Insulitis, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes, Insulitis, Pancreas Inflamed
- What is being tested?
- Definity Suspension for Injection
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to Sep 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
- No additional 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:
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- 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
Who cannot join
- 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)
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- 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz, Barbara Davis Center
Aurora, Colorado, 80045
Hali C Broncucia, MA, 303-724-7526, hali.broncucia@cuanschutz.edu
Morgan Sooy, MS, 303-724-5686, morgan.sooy@cuanschutz.edu
About this study
Official title: Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes
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.
Read the detailed description
Study Design and Research Methods
Part I:
5 subjects from SOP group Goal: Optimize settings for destruction-replenishment contrast-enhanced ultrasound scan
- Subject recruited at the Barbara Davis Center
- Subject provides written consent
- Review medical history (exclusion if required)
- Subject refrains from eating for ~6h prior to measurement
- Subject visits University of Colorado Hospital CTRC echo lab
- CTRC staff places peripheral intravenous line (PIV)
- Research staff collects vital signs, height and weight
- Subject received conventional ultrasound scan to locate pancreas tail (by Sonographer, verified by radiologist).
- Subject receives DEFINITY dose
- Subject receives destruction-replenishment contrast-enhanced ultrasound scan (adjust settings to optimize)
- Pause for 30 minutes, allowing subject to stand and move
- Repeat steps 9-11 (once).
- Subject de-identified.
- Analyze data.
Part II:
30 subjects from control group (healthy controls and multiple islet autoantibody positive subjects), 15 subjects from T1D group.
Goal: characterize subject variability and test whether healthy subjects and those with T1D show differing contrast measures
- Subject recruited at the Barbara Davis Center
- Subject provides written consent
- Review medical history (exclusion if required)
- Subject refrains from eating for ~6h prior to study
- Subject visits University of Colorado Hospital CTRC echo lab
- Subject completes questionnaire (family history of diabetes, exclusion criteria)
- CTRC staff places peripheral intravenous line (PIV)
- Research staff collects vital signs, height and weight
- Subject received conventional ultrasound scan to locate pancreas tail (by Sonographer, verified by radiologist).
- Subject receives DEFINITY dose
- Subject receives destruction-replenishment contrast-enhanced ultrasound scan (under SOP)
- Pause for 30 minutes, allowing subject to stand and move
- Repeat steps 10-12 (once).
- Subject de-identified
- Analyze data.
In part I a single repeat measurement may be made to aide in the optimization of data collection. In part II a single repeat measurement is made to assess short-term intra-subject measurement variability.
In part I and part II, a subject will be asked to return on a separate date (within 1 year of the initial scan) for a repeat procedure using an additional DEFINITY delivery method (bolus or infusion, whichever was not given at the initial visit) or if data collection was not of sufficient quality during the first visit.
- Conditions
- Type1diabetes, Insulitis, Pancreas Inflamed
- Being tested
- Definity Suspension for Injection
- Keywords
- ultrasound, tissue perfusion, contrast, diabetes, pancreas
- Medical subject headings
- Pancreatitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definity Suspension for InjectionDrug
Also called DEFINITY
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | SOP (healthy) subjects. Part I of study (optimizing protocol). Receives: Drug: Definity Suspension for Injection | |
| Group 2 | Control (healthy and autoantibody positive) subjects. Part II of study (cross-sectional study) Receives: Drug: Definity Suspension for Injection | |
| Group 3 | T1D subjects. Part II of study (cross-sectional study) Receives: Drug: Definity Suspension for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome 1
Optimized a contrast-enhanced ultrasound 'destruction-replenishment' protocol for imaging pancreas blood flow kinetics in adult human subjects.
Measured: 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.
Measured: 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
Measured: 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.
Measured: End of part II (1 year)
Secondary outcomes (6)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: End of part II (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start27 Feb 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard KP Benninger, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482321
- Sponsor's protocol ID
- 19-1543
- Status last verified
- May 2026
- First submitted
- 28 Jul 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No