Trial record 9 of 1086 for:
senior [AGE-GROUP] AND exercise [TREATMENT] | Open Studies
Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD
This study is currently recruiting participants.
Verified February 2013 by Duke University
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Jason Allen, Ph.D., Duke University
ClinicalTrials.gov Identifier:
NCT01785524
First received: February 5, 2013
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Arterial Disease and Type II Diabetes Mellitus |
Drug: Beetroot Juice (Beet-It Stamina Shot) and Exercise Training Other: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (PAD) |
Resource links provided by NLM:
MedlinePlus related topics:
Diabetes
Diabetes Type 2
Exercise and Physical Fitness
Peripheral Arterial Disease
Vascular Diseases
U.S. FDA Resources
Further study details as provided by Duke University:
Primary Outcome Measures:
- Change in Exercise Capacity [ Time Frame: Baseline & 16 Weeks ] [ Designated as safety issue: No ]Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.
Secondary Outcome Measures:
- Change in Functional Ability [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: No ]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.
- Change In Vascular Function [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]Ankle-brachial Index (ABI), Brachial artery flow-mediated dilation (BAFMD), calf blood flow (plethysmography), and arterial stiffness (pulse wave velocity and pulse wave reflection).
- Change in Angiogenesis [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]Gastrocnemius muscle biopsy will be performed to measure markers of angiogenesis including; capillaries per unit area and per muscle fiber, endothelial cells with surrounding pericytes, relative fraction of type I, IIa, IIb, and IId/x fibers. If differences exist we will look for changes in cell proliferation (PCNA) and apoptosis (TUNEL); (b) oxidative capacity including; mitochondria volume with citrate synthase activity. (c) mitochondrial volume and density; (d) mitochondrial oxygen efficiency (respiratory control ratio, the ratio of ATP phosphorylation rate per oxygen consumption rate (P/O ratio), and maximal rate of ATP production). These are measurements for potential mediation analyses and gaining insight into the relative effect sizes will inform mechanistic aims in a larger trial.
| Estimated Enrollment: | 28 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training
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.
|
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 Name: James White Drinks
|
|
Placebo Comparator: BR Juice Placebo and Exercise Training
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.
|
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.
Other Name: James White Drinks
|
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Peripheral Arterial Disease (ABI of less than 0.9)
- Diagnosed Type II Diabetes
- Intermittent Claudication for 3 or more months
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785524
Contacts
| Contact: Mitch D VanBruggen, M.A. | 919-660-6638 | mitch.vanbruggen@duke.edu |
| Contact: Katherine L Ham, M.S. | 919-660-6793 | katherine.ham@duke.edu |
Locations
| United States, North Carolina | |
| Duke Center for Living; Wallace Clinic | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Jason D Allen, PhD 919-660-6764 j.d.allen@duke.edu | |
Sponsors and Collaborators
Duke University
Investigators
| Principal Investigator: | Jason D Allen, PhD | Duke University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jason Allen, Ph.D., Assistant Professor Doctor of Physical Therapy Program & Division of Cardiovascular Medicine, Duke University |
| ClinicalTrials.gov Identifier: | NCT01785524 History of Changes |
| Other Study ID Numbers: | Pro00039608 |
| Study First Received: | February 5, 2013 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Duke University:
|
Cardiovascular Diseases Vascular Diseases Arterial Occlusive Diseases |
Diabetes Exercise Functional Capacity |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Peripheral Arterial Disease Peripheral Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013