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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

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