Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change in vascular endothelial function
研究概览
简要总结
The study objectives are:
- To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.
- To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.
- To examine the mechanisms underlying the exercise-related changes in cardiovascular function.
The investigators hypothesize that compared to continuous moderate intensity exercise training, interval training will be more effective in improving cardiovascular function in adults with type 2 diabetes.
详细描述
Cardiovascular function will be measured at baseline in adults with type 2 diabetes and in age-matched healthy controls. Research volunteers with type 2 diabetes who meet the inclusion criteria will be randomized to the aerobic interval training group, continuous moderate exercise group or non-exercise control group. At the end of the 8-week randomized control exercise intervention, baseline measures will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for type 2 diabetes :
- •Diagnosis of type 2 diabetes
- •Sedentary or minimally physically active for at least the prior 1 year
- •Able to give consent
- •Inclusion criteria for healthy control group:
- •Sedentary or minimally physically active for at least the prior 1 year
- •Able to give consent
排除标准
- •History of diabetic proliferative retinopathy, autonomic or peripheral neuropathy
- •History of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)
- •Hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
- •History of renal impairment
- •History of gout or hyperuricemia
- •History of hepatic disease or infection with hepatitis B, C
- •History of seizures, or other relevant on-going or recurrent illness
- •Recent (within 3 months) or recurrent hospitalizations
- •Use of tobacco products
- •>5 % weight change in the prior 6 months.
- •Current intake of medications that may affect study results
- •Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
- •Pregnancy (positive urine pregnancy test) or lactation
- •For the healthy control group, history of diabetes.
研究组 & 干预措施
High intensity aerobic interval training
Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training.
干预措施: High intensity aerobic interval training (Other)
Continuous moderate intensity exercise
Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training.
干预措施: Continuous moderate intensity exercise (Other)
Non-exercise control group
Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks.
Healthy control group
Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only.
结局指标
主要结局
Change in vascular endothelial function
时间窗: At baseline and after 8 weeks of exercise training
Brachial flow mediated dilation using ultrasonography
次要结局
- Change in factors related with endothelial function(At baseline and after 8 weeks of exercise training)
- Change in arterial stiffness(At baseline and after 8 weeks of exercise training)
- Change in cardiac function(At baseline and after 8 weeks of exercise training)
- Change in maximal oxygen consumption(At baseline and after 8 weeks of exercise training)