The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Pulse Wave Velocity
研究概览
简要总结
Arterial vascular disease is the major cause of morbidity and mortality for Type 1 diabetic patients (DM1). Metabolic insulin resistance (metIR), even in the absence of hyperglycemia, conveys a 1.5 to 3-fold increased CVD risk in the general population. Metabolic Insulin Resistance (MetIR) has been repeatedly shown to be prevalent in adults and adolescents with DM1. MetIR in obesity and DM2 are accompanied by vascular insulin resistance (vasIR) which is characterized by impaired vasodilatory action of insulin on resistance or microvascular vessels. VasIR has not been systematically studied in DM1. We hypothesize that in young adults DM1 impairs both baseline and insulin-responsive vascular function throughout the arterial vasculature.
详细描述
In our study, 20 healthy control subjects will be compared to 20 DM1 patients (18-40 yrs). We will assess function in conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin clamp.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-40
- •Healthy with no chronic illness (control group only)
- •Normal screening labs or no clinically significant values
- •DM1 subjects will have been on insulin for at least 5 years and HbA1c <9
排除标准
- •First degree relative with Type 1 or 2 Diabetes (for control group only)
- •Smoking presently or in the past 6 months
- •Medications that affect the vasculature (except ACE or ARB in DM1 subjects, although they will need to be off these drugs for 2 weeks prior to study).
- •Elevated LDL cholesterol > 160
- •BP <100/60 or >160/90
- •Pulse oximetry <90%
- •Pregnant or breastfeeding
- •History of cardiovascular disease, cerebral vascular disease, peripheral vascular disease, liver disease
- •Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam ).
- •Known hypersensitivity to perflutren (contained in Definity)
- •For DM1 group:
- •HbA1c ≥ 9
- •Microalbuminuria
- •Retinipathy
- •Ketoacidosis within the past year.
结局指标
主要结局
Pulse Wave Velocity
时间窗: after 2 hour insulin clamp
vascular measure
Flow Mediated Dilation
时间窗: after 2 hour insulin clamp
vascular measure
Augmentation Index
时间窗: after 2 hour insulin clamp
vascular measure
Contrast Enhanced Ultrasound
时间窗: after 2 hour insulin clamp
vascular measure
次要结局
未报告次要终点
研究者
Eugene Barrett
Professor Eugene Barrett MD PhD
University of Virginia