๐ฌIn plain words
What the trial is, and whether it could suit you
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 wit
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๐ Eligibility rules (as published)
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 ฮฒ-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
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