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NCT01785524 · ClinicalTrials.gov registry record · Phase 2
Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01785524: Completed Phase 2 study, sponsored by Duke University.
NCT01785524 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01785524, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study 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.
Primary Outcome
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption
Interventions
- OTHER Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
- DRUG Beetroot Juice (Beet-It Stamina Shot) and Exercise Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT01785524 record still lists
NCT01785524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training is the first listed.
NCT01785524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01785524 about?
NCT01785524 is a clinical study titled "Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD". 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 traini...
What is the current status of trial NCT01785524?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2013-02. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01785524?
The interventions under investigation include: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training (OTHER), Beetroot Juice (Beet-It Stamina Shot) and Exercise Training (DRUG).
Who is sponsoring clinical trial NCT01785524?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01785524's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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