Phase 2
N=11
Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
Peripheral Arterial Disease · Type II Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01785524 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak) — 0.85; -0.15 ml/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Beetroot Juice (Beet-It Stamina Shot) and Exercise Training (Drug); Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak) |
0.85; -0.15 | — |
| PRIMARY Change in Exercise Capacity - Time to Exhaustion (TTE) |
196.25; 247.5 | — |
| PRIMARY Change in Exercise Capacity - Claudication Onset Time (COT) |
189; 77.5 | — |
| SECONDARY Change in Functional Ability |
131; 47.5 | — |
| SECONDARY Change in Angiogenesis |
2 | — |
| SECONDARY Change In Vascular Function |
1.83; -3.56 | — |
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
Data sourced from ClinicalTrials.gov (NCT01785524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.