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Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD (DM+PAD)

Primary Purpose

Peripheral Arterial Disease, Type II Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Cardiovascular Diseases, Vascular Diseases, Arterial Occlusive Diseases, Diabetes, Exercise, Functional Capacity

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Peripheral Arterial Disease (ABI of less than 0.9)
  • Diagnosed Type II Diabetes
  • Intermittent Claudication for 3 or more months

Exclusion Criteria:

  • Individuals with known alcohol or drug abuse problems
  • Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months
  • Those classified as American Heart Association Class D
  • Gangrene, impending limb loss or osteomyelitis
  • Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
  • Severe peripheral neuropathy
  • Any condition other than PAD that limits walking
  • Chest pain during treadmill exercise which appears before the onset of claudication, or >3mm ST depression during exercise
  • Subjects taking nitrates or nitroglycerin products
  • Must not be taking protein pump inhibitor medications

Sites / Locations

  • Duke Diet & Fitness Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training

BR Juice Placebo and Exercise Training

Arm Description

Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.

Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.

Outcomes

Primary Outcome Measures

Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption
Change in Exercise Capacity - Time to Exhaustion (TTE)
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Time to Exhaustion (TTE)
Change in Exercise Capacity - Claudication Onset Time (COT)
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Claudication Onset Time (COT)

Secondary Outcome Measures

Change in Functional Ability
Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.
Change in Angiogenesis
Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups.
Change In Vascular Function
Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD)

Full Information

First Posted
February 5, 2013
Last Updated
July 26, 2017
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01785524
Brief Title
Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
Acronym
DM+PAD
Official Title
Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (PAD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The hypothesis of this proposal is that in subjects with Type II diabetes mellitus (T2D) and peripheral arterial disease (PAD) with intermittent claudication (IC), regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in claudication onset time [COT] and peak walking time [PWT] relative to a group with the same exercise training but supplemented with placebo .This study is essentially exploratory in nature and designed to provide us with information to adequately develop power and execute a larger study. We have previously seen benefits from nitrate supplementation on function in PAD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Type II Diabetes Mellitus
Keywords
Cardiovascular Diseases, Vascular Diseases, Arterial Occlusive Diseases, Diabetes, Exercise, Functional Capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training
Arm Type
Experimental
Arm Description
Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Arm Title
BR Juice Placebo and Exercise Training
Arm Type
Placebo Comparator
Arm Description
Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.
Intervention Type
Drug
Intervention Name(s)
Beetroot Juice (Beet-It Stamina Shot) and Exercise Training
Other Intervention Name(s)
James White Drinks
Intervention Description
The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training.
Intervention Type
Other
Intervention Name(s)
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
Other Intervention Name(s)
James White Drinks
Intervention Description
The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.
Primary Outcome Measure Information:
Title
Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)
Description
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption
Time Frame
Baseline & 16 Weeks
Title
Change in Exercise Capacity - Time to Exhaustion (TTE)
Description
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Time to Exhaustion (TTE)
Time Frame
Baseline & 16 Weeks
Title
Change in Exercise Capacity - Claudication Onset Time (COT)
Description
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Claudication Onset Time (COT)
Time Frame
Baseline & 16 Weeks
Secondary Outcome Measure Information:
Title
Change in Functional Ability
Description
Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.
Time Frame
Baseline and 16 Weeks
Title
Change in Angiogenesis
Description
Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups.
Time Frame
Baseline and 16 weeks
Title
Change In Vascular Function
Description
Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD)
Time Frame
Baseline and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Peripheral Arterial Disease (ABI of less than 0.9) Diagnosed Type II Diabetes Intermittent Claudication for 3 or more months Exclusion Criteria: Individuals with known alcohol or drug abuse problems Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months Those classified as American Heart Association Class D Gangrene, impending limb loss or osteomyelitis Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment Severe peripheral neuropathy Any condition other than PAD that limits walking Chest pain during treadmill exercise which appears before the onset of claudication, or >3mm ST depression during exercise Subjects taking nitrates or nitroglycerin products Must not be taking protein pump inhibitor medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason D Allen, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Diet & Fitness Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29976553
Citation
Woessner M, VanBruggen MD, Pieper CF, Sloane R, Kraus WE, Gow AJ, Allen JD. Beet the Best? Circ Res. 2018 Aug 31;123(6):654-659. doi: 10.1161/CIRCRESAHA.118.313131.
Results Reference
derived
Links:
URL
http://cardiology.medicine.duke.edu/research/clinical-research/frederick-r-cobb-non-invasive-vascular-research-laboratory
Description
Frederick R. Cobb Non-Invasive Vascular Research Laboratory
URL
http://www.dukehealth.org/clinicaltrials/20130131152500519
Description
Duke Clinical Trials Listing

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Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD

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