Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 50 - 80 |
| Updated: | 7/28/2017 |
| Start Date: | February 2013 |
| End Date: | November 2014 |
Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (PAD)
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.
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.
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
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