drugset / Trial / NCT01785524

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

NCT01785524 ↗

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-02
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Beetroot Juice Other / unclassified 4.2 mmol Oral
Subject Beetroot Juice Other / unclassified 70 ml Oral