Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
Condition: Peripheral Arterial Disease; Type II Diabetes Mellitus
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Diabetes Mellitus, Type 2
Intervention: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training; Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Diabetes; Exercise; Functional Capacity

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.
    

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