Skip to main content
OpenTrials
Completed

NCT Number: NCT01785524

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Peripheral Vascular Diseases Type II Diabetes Mellitus Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke Diet & Fitness Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beetroot Juice (Beet-It Stamina Shot) and Exercise Training

Drug

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 names: James White Drinks

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

Other

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 names: James White Drinks

Primary outcomes

  1. 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

  2. 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)

  3. 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)

Secondary outcomes

  1. Change in Functional Ability

    Time frame: Baseline and 16 Weeks

    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.

  2. Change in Angiogenesis

    Time frame: Baseline and 16 weeks

    Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups.

  3. Change In Vascular Function

    Time frame: Baseline and 16 weeks

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: DM+PAD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 7, 2013
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.