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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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