NCT01785524

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

Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (PAD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease
• Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Beetroot Juice (Beet-It Stamina Shot) and Exercise Training	The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training.
OTHER	Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training	The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-02-07
• Last updated: 2017-07-27
• Results posted: 2016-01-05

Locations

1 site across 1 country: United States