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NCT Number: NCT02206074

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

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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peninsula NIHr Exeter Clinical Research Facility

Exeter, Devon, EX2 5DW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Beetroot

Dietary Supplement

Other names: James Whites Drinks beetroot sports shot

Primary outcomes

  1. Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems

    Time frame: 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.

Secondary outcomes

  1. Functional capacity measured by 6-Minute Walking Test (6MWT)

    Time frame: 6 minutes walking per participant per visit

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Diabetes UK

Registry information

Acronym: Ex nit as

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 1, 2014
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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