RECRUITING

Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease

Talk to us

Conditions

Peripheral Artery DiseasePeripheral Vascular DiseasesPeripheral Arterial DiseasePeripheral Arterial Occlusive Disease

Quick Navigation

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 artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. There will be a follow-up visit to assess blood work after diroximel fumarate.

Official Title

Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease

Quick Facts

Study Start:2024-11-14
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06319339

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:50 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide written informed consent
  2. * 50-75 years of age
  3. * Diagnosed as Fontaine stage II-III
  4. * History of exercise-induced claudication
  5. * Females must be postmenopausal (cessation of menses for \> 24 months)
  6. * Normal renal function (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min)
  7. * Normal hepatic function (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L)
  8. * Complete blood count:
  9. * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
  10. * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
  11. * Able to provide written informed consent
  12. * 50-75 years of age
  13. * No evidence of peripheral occlusive disease (ankle-brachial index \> 0.90)
  14. * Females must be postmenopausal (cessation of menses for \> 24 months)
  15. * Normal renal function (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min)
  16. * Normal hepatic function (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L)
  17. * Complete blood count:
  18. * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
  19. * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
  1. * • Pain at rest and/or tissue loss due to PAD (Fontaine stage IV PAD)
  2. * Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
  3. * Limited walking capacity from conditions other than PAD
  4. * No physical exam to assess exercise limitations in the past year
  5. * Currently pregnant or nursing
  6. * Blood work and medical history NOT demonstrating:
  7. * Normal renal function (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min)
  8. * Normal hepatic function (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L),
  9. * Diagnosis of multiple sclerosis or psoriasis
  10. * Diagnosis of gastrointestinal disorders (e.g., moderate IBS, Crohn's disease, etc.
  11. * Concomitant use of dimethyl fumarate
  12. * Hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY
  13. * Ulcers, gangrene, or necrosis of the foot (Fontaine stage IV PAD)
  14. * Complete blood count NOT within ranges:
  15. * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
  16. * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
  17. * Positive diagnosis of PAD
  18. * No physical exam to assess exercise limitations in the past year
  19. * Any exercise limitations as determined at last physical exam
  20. * Limited walking capacity from musculoskeletal injury
  21. * Currently pregnant or nursing
  22. * Renal function not within normal ranges (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min)
  23. * Hepatic function not within normal ranges (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L)
  24. * Complete blood count NOT within ranges:
  25. * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
  26. * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L

Contacts and Locations

Study Contact

Song-Young Park, PhD
CONTACT
402-554-3374
song-youngpark@unomaha.edu

Principal Investigator

Song-Young Park, PhD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

University of Nebraska - Omaha
Omaha, Nebraska, 68182
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Song-Young Park, PhD, PRINCIPAL_INVESTIGATOR, University of Nebraska

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 Date2024-11-14
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-11-14
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Peripheral Artery Disease
  • Peripheral Vascular Diseases
  • Peripheral Arterial Disease
  • Peripheral Arterial Occlusive Disease