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

Duke University18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Peripheral Arterial Disease Type II Diabetes Mellitus

Interventions

Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise TrainingOTHER

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: Baseline & 16 Weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline and 16 weeks

Change In Vascular Function

Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD)

Time frame: Baseline and 16 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes