The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise
Ex nit as
2 other identifiers
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 25, 2014
CompletedFirst Posted
Study publicly available on registry
August 1, 2014
CompletedMarch 19, 2019
March 1, 2019
1.3 years
July 25, 2014
March 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems
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.
3 x 6 minutes of gas exchange per participant, twice, 10-14 days apart
Secondary Outcomes (1)
Functional capacity measured by 6-Minute Walking Test (6MWT)
6 minutes walking per participant per visit
Study Arms (2)
T2DM
ACTIVE COMPARATORCrossover design where participants will start in the Beetroot juice condition, and after a washout period, move into the other condition.
Placebo
PLACEBO COMPARATORCrossover design where participants will start in the placebo condition, and after a washout period, move into the other condition.
Interventions
Eligibility Criteria
You may qualify if:
- patients with T2D (as defined by WHO) of at least 5 years duration between the ages of 35-75 will be invited.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Exeterlead
- Diabetes UKcollaborator
Study Sites (1)
Peninsula NIHr Exeter Clinical Research Facility
Exeter, Devon, EX2 5DW, United Kingdom
Related Publications (1)
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.
PMID: 25998421DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daryl Wilkerson, PhD
University of Exeter
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2014
First Posted
August 1, 2014
Study Start
May 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
March 19, 2019
Record last verified: 2019-03