Recruiting

Ultrasound Imaging

Sponsor:

University of Colorado, Denver

Code:

NCT05482321

Conditions

Type1diabetes

Insulitis

Pancreas Inflamed

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Definity Suspension for Injection

Study Details

Brief 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 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.

Conditions

Type1diabetes

Insulitis

Pancreas Inflamed

Study ID

NCT05482321

Start date

Feb 27, 2023

Status verified date

May, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

SOP (healthy) subjects. Part I of study (optimizing protocol).

Group 2

Control (healthy and autoantibody positive) subjects. Part II of study (cross-sectional study)

Group 3

T1D subjects. Part II of study (cross-sectional study)

Interventions

Definity Suspension for Injection

  • 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).

Primary outcome measure

  • Primary outcome 1 [ Time Frame: End of part I (6 months) ]
  • Primary outcome 2 [ Time Frame: End of part II (1 year) ]
  • Primary outcome 3 [ Time Frame: End of part II (1 year) ]
  • Primary outcome 4 [ Time Frame: End of part II (1 year) ]

Central Contacts and Locations

Central contacts

Morgan Sooy

303 724 7526morgan.sooy@cuanschutz.edu

Hali Broncucia

303 724 7526hali.broncucia@cuanschutz.edu

Locations

University of Colorado Anschutz, Barbara Davis Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Hali C Broncucia, MA

303-724-7526hali.broncucia@cuanschutz.edu

Morgan Sooy, MS

303-724-5686morgan.sooy@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • ultrasound
  • tissue perfusion
  • contrast
  • diabetes
  • pancreas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-06.