RECRUITING

The Effects of Oral Inorganic Nitrate Supplementation on Lower Limb Perfusion During Exercise in Patients With PAD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Peripheral arterial disease (PAD) is a highly prevalent and costly condition. Intermittent claudication (IC), defined as ischemic leg pain that occurs with walking, results in functional impairment, reduced daily physical activity, and a lower quality of life. Although the mechanisms contributing to functional impairment are not fully delineated, current evidence suggests that the uncoupling of skeletal muscle cellular metabolism from tissue perfusion may be responsible for exercise intolerance. We have previously shown increases in plasma inorganic nitrite, via oral nitrate, produced clinically significant increases exercise performance in patients with PAD+IC. The hypothesis of this proposal is in patients with PAD+IC, 3-6 days of oral dietary nitrate consumption (in the form of concentrated beetroot juice) will produce a greater tissue perfusion, oxygen delivery, and enhanced muscle metabolism in comparison to placebo. This will translate into an increase in physical performance in both muscle specific plantar flexion exercise and treadmill measures of pain free ambulation. In order to test this hypothesis, we will recruit 10 patients PAD+IC in a randomized, double-blind, placebo controlled, cross over design.

Official Title

The Effects of Oral Inorganic Nitrate Supplementation on Lower Limb Perfusion and Metabolism During Exercise in Patients With Peripheral Arterial Disease (PAD)

Quick Facts

Study Start:2020-02-01
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05036213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * - History of stable intermittent claudication for 3 or more months, and an Ankle-brachial index test (ABI) \<0.9 at rest.
  2. * Symptomatic PAD (claudication or critical limb ischemia)
  1. * - Limb threatening ischemia, including rest pain and/or gangrene; impending limb loss or chronic osteomyelitis.
  2. * Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment;
  3. * severe peripheral neuropathy or any condition other than PAD that limits walking such as unstable angina;
  4. * history of significant left main or three vessel coronary artery disease (\>70% stenosis, unprotected by grafts) or recent myocardial infarction (6 weeks);
  5. * chest pain during treadmill exercise which appears before the onset of claudication,
  6. * chronic renal failure with an eGRF\<30; Type 1diabetes mellitus, a BMI\>40, and a HbA1c\>8.5%. Refusal to give or inability to give informed consent. Pregnancy (Self-reported).

Contacts and Locations

Study Contact

Casey C Derella, PhD
CONTACT
434-243-8677
bxg7vn@virginia.edu

Principal Investigator

Jason D. Allen, PhD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Jason D. Allen, PhD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-01
Study Completion Date2024-12

Study Record Updates

Study Start Date2020-02-01
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • PAD
  • nitrate
  • nitric oxide

Additional Relevant MeSH Terms

  • Peripheral Arterial Disease
  • Peripheral Vascular Diseases