Physical Activity and Obesity: The Role of Nitric Oxide and Eicosanoids in Regulating Capillary Perfusion and Vascular Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Insulin mediated skeletal muslce blood flow and capillary recruitment
研究概览
简要总结
The purpose of the study is to see if a twelve-week exercise intervention in overweight or obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved skeletal muscle capillary blood flow by improving substances that dilate blood vessels and result in improved insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 30-60 years of age
- •Overweight and Obese (28< BMI <45)
- •Confirmed pre-diabetic (5.7≤ HbA1c < 6.5)
- •Type 2 DM, Diagnosis 2 years or less, on no medications or metformin only, HbA1c ≤ 6.7
排除标准
- •Stage 3 chronic kidney disease (glomerular filtration rate [GFR] < 60)
- •Obstructive Coronary artery disease
- •Congestive heart failure (ejection fraction < 55%)
- •Peripheral vascular disease,
- •Degenerative joint disease, musculoskeletal disease, or peripheral vascular disease that limits ability to exercise
- •Know hypersensitivity to Definity® ultrasound contrast agent
- •Intra-cardiac or pulmonary shunt
- •The use of antithrombotic agents or a severe bleeding diathesis due to risk of bleeding with intravenous and arterial line placement
- •Physical activity greater than three hours per week
研究组 & 干预措施
High Activity Group
Subject randomized to High Activity group will have 36, one hour training sessions over 12 weeks.
干预措施: High Activity (Behavioral)
Standard of Care Group
The standard of care group will maintain their baseline level of activity for 12 weeks
结局指标
主要结局
Insulin mediated skeletal muslce blood flow and capillary recruitment
时间窗: 3 months
Contrast enhanced ultrasound skeltal muscle perfusion imaging will be performed at rest and during glucose steady state infusion during an insulin clamp. The change in blood flow will be determined between the resting state and at peak steady state to determine the absolute increase in skeletal muslce blood flow (ml/min/g) as well as the absolute increase in capillary blood volume (ml/g) of tissue
次要结局
- Quantification of endothelial derived Vasodilators(3 months)
研究者
Scott M. Chadderdon
Assistant Professor Cardiovascular Medicine
Oregon Health and Science University