Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp
研究概览
简要总结
The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults
详细描述
The investigators will study 22 healthy subjects (18-35 yrs) four times as follows:
- Saline + Octreotide + euglycemia;
- Octreotide + hyperglycemia;
- Octreotide + hyperglycemia + insulin clamp and
- Octreotide + Euglycemia + insulin clamp.
The sequence of admissions will be assigned randomly. The investigators will assess function in conduit (pulse wave velocity-PWV, augmentation index-AI and flow-mediated dilation-FMD), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels.
This work will:
a) identify whether vascular stiffness and indices of NO action are impaired throughout the arterial tree with hyperglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy with no chronic illness
- •Age 18-35
- •Normal BMI (18-25)
- •Normal screening labs or no clinically significant values
排除标准
- •First degree relative with Type 2 Diabetes
- •Smoking presently or in the past 6 months
- •Medications that affect the vasculature
- •Overweight or other indications of insulin resistance
- •Elevated LDL cholesterol > 160
- •Elevated BP > 140/90
- •History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease, bleeding disorders
- •Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease
- •Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).
- •Pregnant or breastfeeding.
- •Known hypersensitivity to perflutren (contained in Definity)
研究组 & 干预措施
Octreotide- Euglycemia
octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
干预措施: Octreotide (Drug)
Octreotide- Euglycemia
octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
干预措施: Insulin (Drug)
Octreotide- Euglycemia
octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
干预措施: Dextrose 20% solution (Drug)
Octreotide - Euglycemia- insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
干预措施: Octreotide (Drug)
Octreotide - Euglycemia- insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
干预措施: Insulin (Drug)
Octreotide - Euglycemia- insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
干预措施: Dextrose 20% solution (Drug)
Octreotide- hyperglycemia
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
干预措施: Octreotide (Drug)
Octreotide- hyperglycemia
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
干预措施: Insulin (Drug)
Octreotide- hyperglycemia
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
干预措施: Dextrose 20% solution (Drug)
Octreotide- hyperglycemia - insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
干预措施: Octreotide (Drug)
Octreotide- hyperglycemia - insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
干预措施: Insulin (Drug)
Octreotide- hyperglycemia - insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
干预措施: Dextrose 20% solution (Drug)
结局指标
主要结局
Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp
时间窗: baseline and after 2 hour insulin clamp
Flow mediated dilation measures the change in brachial diameter in response to 5 minutes of ischemia using B-mode ultrasound. It provides an index of nitric oxide generation by the endothelium .
次要结局
- Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp(baseline and after 2 hour insulin clamp)
- Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp(baseline and after 2 hour insulin clamp)
研究者
Eugene Barrett
Prinicipal Investigator
University of Virginia