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临床试验/NCT01883258
NCT01883258已完成不适用

Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes

University of Florida2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
2
主要终点
Change in vascular endothelial function

研究概览

简要总结

The study objectives are:

  1. To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.
  2. To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.
  3. 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

入选标准

  • 未提供

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.

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 cardiac function(At baseline and after 8 weeks of exercise training)
  • 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 maximal oxygen consumption(At baseline and after 8 weeks of exercise training)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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