Nitrites, Exercise, and Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— NO-PAD  

Official title:

Increased Plasma Nitrite, Tissue Oxygenation and Functional Changes in PAD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684930
• Other study ID #: Pro00031918
• Secondary ID: 1R21HL111972-01
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2012
• Last updated: August 26, 2017
• Start date: June 2012
• Est. completion date: November 2014

Study information

• Verified date: August 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypothesis of this proposal is that in subjects with PAD, 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 COT and PWT) than placebo plus supervised exercise at the limb ischemic threshold (PET).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Peripheral Arterial Disease (ABI of less than 0.9)

• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Beetroot Juice (Beet-It Stamina Shot) & Supervised 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.

Locations

Country	Name	City	State
United States	Duke Diet & Fitness Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)	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.	Baseline and 16 Weeks
Primary	Change In Time To Exhaustion	Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of total time to exhaustion.	Baseline and 16 weeks
Secondary	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.	Baseline and 16 Weeks
Secondary	Change In Claudication Onset Time	Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of claudication onset time.	Baseline and 16 weeks
Secondary	Change In Vascular Function (BAFMD)	Vascular Function is measured as Brachial artery flow-mediated dilation (BAFMD). BAFMD is a measure of change in artery diameter after a stimulus .	Baseline and 16 weeks
Secondary	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	Baseline and 16 weeks

External Links

•   Duke Clinical Trials Listing
•   Frederick R. Cobb Non-Invasive Vascular Research Laboratory