Clinical trial NCT02206074: The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise
Official title: The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Diabetes UK
First posted: 2014-08-01
Enrollment: 57
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems
timeFrame: 3 x 6 minutes of gas exchange per participant, twice, 10-14 days apart
Secondary outcomes:
measure: Functional capacity measured by 6-Minute Walking Test (6MWT)
timeFrame: 6 minutes walking per participant per visit
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Peninsula NIHr Exeter Clinical Research Facility
state: Devon
Study officials:
affiliation: University of Exeter
name: Daryl Wilkerson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shepherd AI, Gilchrist M, Winyard PG, Jones AM, Hallmann E, Kazimierczak R, Rembialkowska E, Benjamin N, Shore AC, Wilkerson DP. Effects of dietary nitrate supplementation on the oxygen cost of exercise and walking performance in individuals with type 2 diabetes: a randomized, double-blind, placebo-controlled crossover trial. Free Radic Biol Med. 2015 Sep;86:200-8. doi: 10.1016/j.freeradbiomed.2015.05.014. Epub 2015 May 18.