Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
Completed · Phase 2 · Has a placebo group
Conditions studied: Peripheral Arterial Disease, Type II Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT01785524
- Run by
- Duke University
- People needed
- 18
- Starts
- 2013-02-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2017-07-27
Who can join
Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Peripheral Arterial Disease (ABI of less than 0.9)
- Diagnosed Type II Diabetes
- Intermittent Claudication for 3 or more months
You may not qualify if…
- 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
Where it is running
- Duke Diet & Fitness Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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