Effects of Exercise and GLP-1 Agonism on Muscle Microvascular Perfusion and Insulin Action in Adults With Metabolic Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 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 skeletal muscle microvascular blood volume, improves vascular function of the conduit vessels, and enhances insulin's metabolic action in humans with Metabolic Syndrome. Subjects will be randomized to one of the 4 groups: control, exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 24 weeks of intervention.
详细描述
Our hypothesis is that sustained activation of the GLP-1 receptor with Liraglutide and exercise training each will enhance microvascular insulin responses and angiogenesis in both cardiac and skeletal muscle to increase muscle insulin delivery and action and the combination of both is more effective than either alone in adults with metabolic syndrome.
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
- •Male or female ≥21 and ≤60 years old.
- •Body mass index >25 and ≤35 kg/m2 and is weight stable (<5 kg weight change in the past 6 months). BMI is limited to ≤35 kg/m2 for easier vascular access and cardiac imaging.
- •Meet 3 of 5 National Cholesterol Education Program Adult Treatment Panel III Metabolic Syndrome criteria:
- •Increased waist circumference (≥102 cm in men; ≥88 cm in women)
- •Elevated triglycerides (≥150 mg/dl)
- •Reduced HDL-cholesterol (<40mg/dl in men, <50 mg/dl in women)
- •High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic)
- •Elevated fasting glucose (≥100 mg/dl)
- •Subject may participate if on the following drugs, provided the drug doses have been stable for at least 3 months.
- •Ace inhibitor
- •HMG CoA reductase inhibitor
- •Beta blocker
- •Calcium channel blockers
- •Alpha-adrenergic antagonist
排除标准
- •A diagnosis of any type of diabetes or history of diabetes medication use
- •Recently active (>20 min of moderate/high intensity exercise, 2 times/week)
- •Subjects who are smokers or who have quit smoking <5 years
- •Subjects with hypertriglyceridemia (>400 mg/dl) or hypercholesterolemia (>260 mg/dl)
- •Subjects with BP>160/90
- •Subjects with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or malignancy
- •Pregnant (as evidenced by positive pregnancy test) or nursing women
- •Subjects with contraindications to participation in an exercise training program
- •Allergic to perflutren
- •A prior use of Liraglutide
研究组 & 干预措施
Exercise Alone
24 weeks of treatment
干预措施: Exercise training (Other)
Liraglutide Alone
24 weeks of treatment
干预措施: Liraglutide (Drug)
Exercise + Liraglutide
24 weeks f treatment
干预措施: Liraglutide + Exercise training (Drug)
结局指标
主要结局
Microvascular Blood Volume - change from baseline
时间窗: 24 weeks
measured at baseline and 24 weeks
次要结局
- Augmentation Index - change from baseline(24 weeks)
- Pulse Wave Velocity(24 weeks)
- Post Ischemic Flow Velocity - change from baseline(24weeks)
- Insulin Sensitivity - change from baseline(24 weeks)
- Flow Mediated Dilation(24 weeks)
研究者
Zhenqi Liu
Professor, Division of Endocrinology and Metabolism
University of Virginia