Effects of Empagliflozin on Cardiac Microvasculature and Insulin Sensitivity in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Myocardial microvascular perfusion
研究概览
简要总结
The aim is to test in T2DM patients, whether, compared to placebo, 12 weeks of SGLT-2 inhibitor improves post-absorptive, post-insulin infusion or postprandial insulin action to enhance Cardiac Muscle vascular function and whether changes correlate with improved GV or postprandial hyperglycemia
详细描述
The investigators will study 32 T2DM subjects measuring cardiac muscle vascular function before and after a 4 hour insulin clamp ( protocol A) and before and after a mixed meal (protocol B). Then subjects will be randomized into 2 groups: Group 1 will undergo a 12 week intervention of Empagliflozin, and Group 2 will do 12 weeks of Placebo. The intervention will be single blinded. At the end of the 12 week intervention subjects will repeat protocol A and B.
The study's primary objective is to assess whether, compared to placebo, 12 weeks of Empagliflozin improves post-absorptive or postprandial insulin action to enhance myocardial perfusion (MP) and whether changes of MP correlate with improved glucose variability or postprandial hyperglycemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A1C > 6.5 and <9%
- •Never on SGLT-2i (eg: Jardiance, Invokana, Farxiga, Steglatro)
- •On stable dose of oral hypoglycemic agents >3 months
- •On stable dose of other medications for >3 months
排除标准
- •• Smoking presently or in the past 6 months
- •Taking insulin
- •BP >160/90
- •History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease.
- •Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease
- •History of cancer or psychiatric 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)
- •Screening O2 saturation <90%
- •History of recurrent UTI/bladder/kidney infections-eGFR is below 45 mL/min/1.73.
研究组 & 干预措施
Empagliflozin + insulin infusion
vascular measurements in overnight fasted state and during insulin infusion
干预措施: Empagliflozin 25 MG (Drug)
Empagliflozin + mixed meal
vascular measurements in overnight fasted state and 2 hours after mixed meal 10kcal/kg body weight ( 55% Cho, 30%Fat, 20% Pro)
干预措施: Empagliflozin 25 MG (Drug)
结局指标
主要结局
Myocardial microvascular perfusion
时间窗: Between baseline and 12 weeks treatment
Vascular measure of myocardial perfusion
次要结局
- Flow Mediated Dilation (FMD) Vascular measure of conduit artery stiffness Change in Flow Mediated Dilation (FMD) between baseline and after 2 hour insulin clamp Vascular measure of conduit artery stiffness Flow Mediated Dilation ( FMD)(Between baseline and 12 weeks of treatment.)
- Augmentation Index ( AI)(Between baseline and 12 weeks of treatment.)
- Pulse Wave Velocity ( PWV)(Between baseline and 12 weeks of treatment)
研究者
Eugene Barrett
Prinicipal Investigator
University of Virginia