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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jason Allen, Ph.D., Duke University
ClinicalTrials.gov Identifier:
NCT01785524
First received: February 5, 2013
Last updated: July 26, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Peripheral Arterial Disease Type II Diabetes Mellitus Drug: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (PAD)

Resource links provided by NLM:


Further study details as provided by Jason Allen, Ph.D., Duke University:

Primary Outcome Measures:
  • Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak) [ Time Frame: Baseline & 16 Weeks ]
    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) [ Time Frame: Baseline & 16 Weeks ]
    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) [ Time Frame: Baseline & 16 Weeks ]
    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 [ Time Frame: Baseline and 16 Weeks ]
    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 [ Time Frame: Baseline and 16 weeks ]
    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 [ Time Frame: Baseline and 16 weeks ]
    Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD)


Enrollment: 18
Study Start Date: February 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training
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.
Drug: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training
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.
Other Name: James White Drinks
Placebo Comparator: BR Juice Placebo and Exercise Training
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.
Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
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.
Other Name: James White Drinks

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785524

Locations
United States, North Carolina
Duke Diet & Fitness Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jason D Allen, PhD Duke University
  More Information

Additional Information:
Responsible Party: Jason Allen, Ph.D., Assistant Professor Doctor of Physical Therapy Program & Division of Cardiovascular Medicine, Duke University
ClinicalTrials.gov Identifier: NCT01785524     History of Changes
Other Study ID Numbers: Pro00039608
5R21HL113717-02 ( U.S. NIH Grant/Contract )
Study First Received: February 5, 2013
Results First Received: November 25, 2015
Last Updated: July 26, 2017

Keywords provided by Jason Allen, Ph.D., Duke University:
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Diabetes
Exercise
Functional Capacity

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Arterial Disease
Peripheral Vascular Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2017