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The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise (Ex nit as)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Beetroot
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peninsula NIHr Exeter Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

T2DM

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2014
Last Updated
March 15, 2019
Sponsor
University of Exeter
Collaborators
Diabetes UK
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1. Study Identification

Unique Protocol Identification Number
NCT02206074
Brief Title
The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise
Acronym
Ex nit as
Official Title
The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter
Collaborators
Diabetes UK

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T2DM
Arm Type
Active Comparator
Arm Description
Crossover design where participants will start in the Beetroot juice condition, and after a washout period, move into the other condition.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Crossover design where participants will start in the placebo condition, and after a washout period, move into the other condition.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot
Other Intervention Name(s)
James Whites Drinks beetroot sports shot
Primary Outcome Measure Information:
Title
Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems
Description
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.
Time Frame
3 x 6 minutes of gas exchange per participant, twice, 10-14 days apart
Secondary Outcome Measure Information:
Title
Functional capacity measured by 6-Minute Walking Test (6MWT)
Time Frame
6 minutes walking per participant per visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daryl Wilkerson, PhD
Organizational Affiliation
University of Exeter
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peninsula NIHr Exeter Clinical Research Facility
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25998421
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.
Results Reference
derived

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

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