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Pancreas Ultrasound Imaging in type1 Diabetes

University of Colorado, Denver · NCT05482321

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
50
US sites recruiting
1
Study start
February 27, 2023
Record last updated
May 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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. 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.

Being studied: Definity Suspension for Injection

Conditions: Type1diabetes; Insulitis; Pancreas Inflamed

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Colorado Anschutz, Barbara Davis Center

    Aurora, CO 80045

    Site contact: Hali C Broncucia, MA · 303-724-7526 · hali.broncucia@cuanschutz.edu

Study contacts (from the official record)

  • Morgan Sooy · 303 724 7526 · morgan.sooy@cuanschutz.edu
  • Hali Broncucia · 303 724 7526 · hali.broncucia@cuanschutz.edu
All diabetes studies in Colorado →
Pancreas Ultrasound Imaging in type1 Diabetes (NCT05482321) | Bored Studies