Peripheral Arterial DiseasePhase 2DM+PADNCT01785524
Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
A Phase 2 study testing Beetroot Juice (Beet-It Stamina Shot) and Exercise Training in people with Peripheral Arterial Disease and Type II Diabetes Mellitus, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease, Type II Diabetes Mellitus
- What is being tested?
- Beetroot Juice (Beet-It Stamina Shot) and Exercise Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral Arterial Disease (ABI of less than 0.9)
- Diagnosed Type II Diabetes
- Intermittent Claudication for 3 or more months
Who cannot join
- Individuals with known alcohol or drug abuse problems
- Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months
- Those classified as American Heart Association Class D
- Gangrene, impending limb loss or osteomyelitis
- Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
- Severe peripheral neuropathy
Show all 10Show fewer
- Any condition other than PAD that limits walking
- Chest pain during treadmill exercise which appears before the onset of claudication, or >3mm ST depression during exercise
- Subjects taking nitrates or nitroglycerin products
- Must not be taking protein pump inhibitor medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Diet & Fitness Center
Durham, North Carolina, 27710
About this study
Official title: Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (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 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.
- Being tested
- Beetroot Juice (Beet-It Stamina Shot) and Exercise Training, Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
- Keywords
- Cardiovascular Diseases, Vascular Diseases, Arterial Occlusive Diseases, Diabetes, Exercise, Functional Capacity
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Vascular Diseases, Arterial Occlusive Diseases, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot Juice (Beet-It Stamina Shot) and Exercise TrainingDrug
Also called James White Drinks
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.
Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise TrainingOther
Also called James White Drinks
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.
| Study group | Role | What they receive |
|---|---|---|
| BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training | Experimental | Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention. Receives: Drug: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training |
| BR Juice Placebo and Exercise Training | Placebo comparator | Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention. Receives: Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption
Measured: Baseline & 16 Weeks
Change in Exercise Capacity - Time to Exhaustion (TTE)
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Time to Exhaustion (TTE)
Measured: Baseline & 16 Weeks
Change in Exercise Capacity - Claudication Onset Time (COT)
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Claudication Onset Time (COT)
Measured: Baseline & 16 Weeks
Secondary outcomes (3)
Change in Functional Ability
Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.
Measured: Baseline and 16 Weeks
Change in Angiogenesis
Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups.
Measured: Baseline and 16 weeks
Change In Vascular Function
Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD)
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jason Allen, Ph.D., Duke University
- Investigators
- Jason D Allen, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785524
- Sponsor's protocol ID
- Pro00039608
- Other IDs
- 5R21HL113717-02
- Acronym
- DM+PAD
- Status last verified
- Jul 2017
- First submitted
- 5 Feb 2013
- Last updated
- 27 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Woessner M, VanBruggen MD, Pieper CF, Sloane R, Kraus WE, Gow AJ, Allen JD. Beet the Best? Circ Res. 2018 Aug 31;123(6):654-659. doi: 10.1161/CIRCRESAHA.118.313131.
PubMed 29976553
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (PAD)
- ClinicalTrials.gov ID
- NCT01785524
- Acronym / sponsor ID
- DM+PAD / Pro00039608
- Keywords
- Cardiovascular Diseases, Vascular Diseases, Arterial Occlusive Diseases, Diabetes, Exercise, Functional Capacity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Posted 5 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training | Experimental | Drug: Beetroot Juice (Beet-It Stamina Shot) and Exercise TrainingSubjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention. |
| BR Juice Placebo and Exercise Training | Placebo comparator | Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise TrainingSubjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Peripheral Arterial Disease (ABI of less than 0.9)
- Diagnosed Type II Diabetes
- Intermittent Claudication for 3 or more months
Key exclusion criteria (10 listed)
- Individuals with known alcohol or drug abuse problems
- Individuals who have suffered a heart attack or stroke, or have changes on a resting ECG, in the last 3 months
- Those classified as American Heart Association Class D
- Gangrene, impending limb loss or osteomyelitis
- Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot Juice (Beet-It Stamina Shot) and Exercise TrainingAlso: James White DrinksThe 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. | Drug | BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training |
| Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise TrainingAlso: James White DrinksThe 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. | Other | BR Juice Placebo and Exercise Training |
Primary outcome
Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)
Time frame: Baseline & 16 Weeks
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption
Change in Exercise Capacity - Time to Exhaustion (TTE)
Time frame: Baseline & 16 Weeks
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Time to Exhaustion (TTE)
Change in Exercise Capacity - Claudication Onset Time (COT)
Time frame: Baseline & 16 Weeks
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Claudication Onset Time (COT)
3 secondary outcomes
Change in Functional Ability
Time frame: Baseline and 16 Weeks
Change in Angiogenesis
Time frame: Baseline and 16 weeks
Change In Vascular Function
Time frame: Baseline and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29976553Woessner M, VanBruggen MD, Pieper CF, Sloane R, Kraus WE, Gow AJ, Allen JD. Beet the Best? Circ Res. 2018 Aug 31;123(6):654-659. doi: 10.1161/CIRCRESAHA.118.313131.
- Frederick R. Cobb Non-Invasive Vascular Research LaboratoryLink provided by the sponsor.
- Duke Clinical Trials ListingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason D Allen, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beetroot Juice (Beet-It Stamina Shot) and Exercise Training in people with Peripheral Arterial Disease and Type II Diabetes Mellitus, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak) (time frame: Baseline & 16 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.