Combining Exercise Training With a Drug to Break AGE-crosslinks; Effects on Cardiovascular Structure and Function and Related Mechanisms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on vascular endothelial function.
研究概览
简要总结
Healthy but sedentary aging leads to increased morbidity and mortality of cardiovascular disease. This is partly due to the accumulation of Advanced Glycation Endproducts (AGEs) and the stiffening of the myocardium and arteries. New medication has been developed to break these AGE-crosslinks to improve cardiovascular compliance. The positive influence of regular physical activity is well known for cardiovascular disease and aging. Therefore, what is the most effective intervention, physical exercise and/or new medication AGE-crosslink breakers, in improving the cardiovascular and cerebrovascular compliance and improving the endothelial function in healthy sedentary elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy sedentary elderly
- •Age 65 yrs and older
排除标准
- •Cardiovascular disease
- •Cerebrovascular disease
- •Changes on ECG indicating cardiomyopathy or ischemia
- •No cardiovascular medication
- •Diabetes Mellitus
- •Hypercholesterolemia
- •BMI > 33 kg/m2
- •Intensive exercise > 1 hour a week
研究组 & 干预措施
Alagebrium
In this study there will be four different groups:
One Alagebrium 100 mg twice daily and exercise training 3x/week Two Placebo twice daily and exercise training 3x/week Three Alagebrium 100 mg twice daily and no exercise training Four Placebo twice daily and no exercise training
干预措施: Alt-711 (Drug)
Alagebrium
In this study there will be four different groups:
One Alagebrium 100 mg twice daily and exercise training 3x/week Two Placebo twice daily and exercise training 3x/week Three Alagebrium 100 mg twice daily and no exercise training Four Placebo twice daily and no exercise training
干预措施: Physical exercise training (Behavioral)
Exercise training
In this study there will be four different groups:
One Alagebrium 100 mg twice daily and exercise training 3x/week Two Placebo twice daily and exercise training 3x/week Three Alagebrium 100 mg twice daily and no exercise training Four Placebo twice daily and no exercise training
干预措施: Alt-711 (Drug)
Exercise training
In this study there will be four different groups:
One Alagebrium 100 mg twice daily and exercise training 3x/week Two Placebo twice daily and exercise training 3x/week Three Alagebrium 100 mg twice daily and no exercise training Four Placebo twice daily and no exercise training
干预措施: Physical exercise training (Behavioral)
结局指标
主要结局
Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on vascular endothelial function.
时间窗: 0 and 12 months
At baseline and 12 months the endothelial function will be measured with an invasive vascular function measurement using the leg model. Via an arterial line in the common femoral artery acethylcholine, sodium nitroprusside and LNMMA will be infused at different dosages. Vascular response will be measured using venous occlusion plethysmography. Non-invasive vascular measurements, e.g.flow mediated dilation and pulse wave velocity, using ultrasound techniques will be performed at 0, 6 and 12 months. Also, cardiopulmonary fitness level will be tested at 0, 3, 6 and 12 months with an ergometer.
次要结局
- Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on vascular endothelial function.(0 and 12 months)
- Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cardiac function.(0, 6 and 12 months)
- Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cardiac function.(0, 6 and 12 months)
- Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cerebral perfusion and cognitive function.(0 and 12 months)
- Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cerebral perfusion and cognitive function.(0 and 12 months)
研究者
Maria Hopman
Prof.Dr. M.T.E. Hopman
Radboud University Medical Center