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

Duke University

Status and phase: Completed; Phase 2

Conditions: Type II Diabetes Mellitus; Peripheral Arterial Disease

Treatments: Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training; Drug: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01785524

Pro00039608

5R21HL113717-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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18 participants in 2 patient groups, including a placebo group

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

Experimental group

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.

Treatment:

Drug: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training

BR Juice Placebo and Exercise Training

Placebo Comparator group

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.

Treatment:

Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training