Overview

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

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Duke University
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)