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临床试验/NCT02206074
NCT02206074已完成不适用

The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise

University of Exeter2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2012年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems

研究概览

简要总结

The investigators are conducting a research study to see if increasing the amount of nitrate (a substance found in large quantities in certain vegetables) in the diet can increase the ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D find exercise more uncomfortable than individuals who do not have T2D. This may be explained by the experimental studies showing that T2D can result in reductions in the supply of oxygen to the muscles. Studies have also shown that for a given level of activity, individuals with T2D will be much closer to their maximum exercise capacity than healthy individuals. Dietary nitrate may have two important beneficial effects in individuals with T2D: 1) The effects of dietary nitrate on the responses to exercise may have a significant impact on the ability of individuals with Type 2 diabetes to perform daily tasks and exercise more comfortably and 2) experimental studies suggest that increased nitrate consumption has been shown to reduce the amount of oxygen required for a given level of exercise.

The investigators will recruit 60 individuals with T2D. These people will take part in a randomised crossover design study where they will be asked to drink normal beetroot juice (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking). This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen required for a given level of exercise in individuals with T2D. To test brain function individuals will be asked to perform a standard computerised decision making task following consumption of the nitrate rich and nitrate depleted juices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with T2D (as defined by WHO) of at least 5 years duration between the ages of 35-75 will be invited.

排除标准

  • patients with significant renal impairment (eGFR<30)
  • uncontrolled hypertension
  • BMI<25 or >35
  • are taking regular organic nitrates, nicorandil, or thiazolidinidiones, or any medication which may interfere with data interpretation or safety
  • who have had a myocardial infarction or cerebro-vascular event
  • who smoke, or any other serious medical condition which would interfere with data interpretation or safety will be excluded from participation.

研究组 & 干预措施

T2DM

Active Comparator

Crossover design where participants will start in the Beetroot juice condition, and after a washout period, move into the other condition.

干预措施: Beetroot (Dietary Supplement)

Placebo

Placebo Comparator

Crossover design where participants will start in the placebo condition, and after a washout period, move into the other condition.

干预措施: Beetroot (Dietary Supplement)

结局指标

主要结局

Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems

时间窗: 3 x 6 minutes of gas exchange per participant, twice, 10-14 days apart

Pulmonary gas exchange was measured during treadmill walking exercise (MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems, St. Paul, MN, USA). Prior to each testing session the analysers were calibrated using known concentrations. The volume transducer was calibrated using a 3-litre syringe (Hans Rudolph, Kansas City, MO, USA). When we refer to the oxygen cost of exercise we are referring to end exercise oxygen uptake.

次要结局

  • Functional capacity measured by 6-Minute Walking Test (6MWT)(6 minutes walking per participant per visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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