Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Primary outcome 3
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1
SOP (healthy) subjects. Part I of study (optimizing protocol).
干预措施: Definity Suspension for Injection (Drug)
Group 2
Control (healthy and autoantibody positive) subjects. Part II of study (cross-sectional study)
干预措施: Definity Suspension for Injection (Drug)
Group 3
T1D subjects. Part II of study (cross-sectional study)
干预措施: Definity Suspension for Injection (Drug)
结局指标
主要结局
Primary outcome 3
时间窗: End of part II (1 year)
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
Primary outcome 1
时间窗: End of part I (6 months)
Optimized a contrast-enhanced ultrasound 'destruction-replenishment' protocol for imaging pancreas blood flow kinetics in adult human subjects.
Primary outcome 2
时间窗: End of part II (1 year)
Comparison of pancreas blood flow kinetics (i.e. 'destruction-replenishment' k2 'reperfusion rate' parameter) between control and T1D subjects.
Primary outcome 4
时间窗: End of part II (1 year)
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.
次要结局
- Secondary outcome 3(End of part II (1 year))
- Secondary outcome 1(End of part II (1 year))
- Secondary outcome 2(End of part II (1 year))
- Secondary outcome 6(End of part II (1 year))
- Secondary outcome 4(End of part II (1 year))
- Secondary outcome 5(End of part II (1 year))