Effect of Exercise and/or Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Microvascular Blood Volume - change from baseline
研究概览
简要总结
The primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and muscle capillary blood volume, improves vascular function in the larger conduit vessels, and enhances insulin's metabolic action in humans with Type 2 diabetes. Subjects will be randomized to one of the three groups: exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 16 weeks of intervention.
详细描述
Our hypothesis is that sustained activation of the GLP-1 receptor with Liraglutide or exercise training will enhance microvascular perfusion, promote angiogenesis, and improve microvascular response to insulin in muscle, leading to increased muscle delivery of oxygen and nutrients and increased exercise tolerance in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-60
- •A1C ≤ 8.5%
- •Never on GLP-1RA (eg: exenatide, liraglutide) or DPP4I ( eg: Sitaglipton)
- •On stable dose of oral hypoglycemic agents >4 months
- •On stable dose of other medications for >4 months
排除标准
- •Taking Insulin
- •Smoking presently or in the past 6 months
- •BP >160/90
- •Family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome
- •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
- •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
Exercise Alone
16 weeks of treatment
干预措施: Exercise (Other)
Exercise + Liraglutide
16 weeks of treatment
干预措施: Exercise (Other)
Liraglutide alone
16 weeks of treatment
干预措施: Liraglutide (Drug)
Exercise + Liraglutide
16 weeks of treatment
干预措施: Liraglutide (Drug)
结局指标
主要结局
Microvascular Blood Volume - change from baseline
时间窗: 16 weeks
measured at baseline and 16 weeks
次要结局
- Flow Mediated Dilation - change from baseline(16 weeks)
- Pulse Wave Velocity - change from baseline(16 weeks)
- Insulin Sensitivity-Change from baseline(16 weeks)
- Augmentation Index - change from baseline(16 weeks)
- Post Ischemic Flow Velocity-Change from baseline(16 weeks)
研究者
Zhenqi Liu
Professor and Chief, Division of Endocrinology and Metabolism
University of Virginia