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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 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01785524
The ClinicalTrials.gov registry entry for NCT01785524 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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