Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD

Peripheral Arterial Disease Clinical Trial

— DM+PAD  

Official title:

Dietary Nitrate to Augment Exercise Training Benefits in Subjects With Type II Diabetes (DM) and Peripheral Arterial Disease (PAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785524
• Other study ID #: Pro00039608
• Secondary ID: 5R21HL113717-02
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2013
• Last updated: July 26, 2017
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: July 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Type II Diabetes Mellitus

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:
• 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 - 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	Baseline & 16 Weeks
Primary	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)	Baseline & 16 Weeks
Primary	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)	Baseline & 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 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
Secondary	Change In Vascular Function	Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD)	Baseline and 16 weeks

External Links

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