RECRUITING

Pancreas Ultrasound Imaging in type1 Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes

Quick Facts

Study Start:2023-02-27
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05482321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or non-pregnant female age 18-65
  2. * Ability and willingness of patient to participate fully in all aspects of this clinical study
  3. * Written informed consent obtained and documented
  1. * Excessive body size preventing effective scan of the pancreas as determined by sonographer
  2. * Evidence of exocrine pancreatic disease, including pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, or neuroendocrine tumor.
  3. * Subjects who are pregnant or breast-feeding
  4. * Subjects incapable of giving assent/informed written consent
  5. * Known or suspected hypersensitivity to perflutren
  6. * Known history or suspected unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)

Contacts and Locations

Study Contact

Morgan Sooy
CONTACT
303 724 7526
morgan.sooy@cuanschutz.edu
Hali Broncucia
CONTACT
303 724 7526
hali.broncucia@cuanschutz.edu

Principal Investigator

Richard KP Benninger, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

University of Colorado Anschutz, Barbara Davis Center
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Richard KP Benninger, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-27
Study Completion Date2025-09

Study Record Updates

Study Start Date2023-02-27
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • ultrasound
  • tissue perfusion
  • contrast
  • diabetes
  • pancreas

Additional Relevant MeSH Terms

  • Type1diabetes
  • Insulitis
  • Pancreas Inflamed