Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (PAD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)
研究概览
简要总结
The hypothesis of this proposal is that in subjects with Type II diabetes mellitus (T2D) and peripheral arterial disease (PAD) with intermittent claudication (IC), regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in claudication onset time [COT] and peak walking time [PWT] relative to a group with the same exercise training but supplemented with placebo .This study is essentially exploratory in nature and designed to provide us with information to adequately develop power and execute a larger study. We have previously seen benefits from nitrate supplementation on function in PAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peripheral Arterial Disease (ABI of less than 0.9)
- •Diagnosed Type II Diabetes
- •Intermittent Claudication for 3 or more months
排除标准
- •Individuals with known alcohol or drug abuse problems
- •Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months
- •Those classified as American Heart Association Class D
- •Gangrene, impending limb loss or osteomyelitis
- •Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
- •Severe peripheral neuropathy
- •Any condition other than PAD that limits walking
- •Chest pain during treadmill exercise which appears before the onset of claudication, or >3mm ST depression during exercise
- •Subjects taking nitrates or nitroglycerin products
- •Must not be taking protein pump inhibitor medications
研究组 & 干预措施
BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training
Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
干预措施: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training (Drug)
BR Juice Placebo and Exercise Training
Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
干预措施: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training (Other)
结局指标
主要结局
Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)
时间窗: Baseline & 16 Weeks
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption
Change in Exercise Capacity - Time to Exhaustion (TTE)
时间窗: Baseline & 16 Weeks
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Time to Exhaustion (TTE)
Change in Exercise Capacity - Claudication Onset Time (COT)
时间窗: Baseline & 16 Weeks
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Claudication Onset Time (COT)
次要结局
- Change in Functional Ability(Baseline and 16 Weeks)
- Change in Angiogenesis(Baseline and 16 weeks)
- Change In Vascular Function(Baseline and 16 weeks)
研究者
Jason Allen, Ph.D.
Assistant Professor Doctor of Physical Therapy Program & Division of Cardiovascular Medicine
Duke University