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The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD

NCT03490968 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-29

No results posted yet for this study

Summary

Test the theory that abnormalities in the large blood vessels that deliver blood to your leg and the very small blood vessels in your leg's muscles (invisible to the eye) work together to worsen your leg function and walking.

Conditions

  • Peripheral Arterial Disease

Interventions

BEHAVIORAL

Supervised Exercise

Subjects will have 3 visits per week for 12 weeks.

BEHAVIORAL

Vascular Assessment

Screen: Subjects will undergo a H\&P, ankle brachial index, ECG, CBC, CMP, lipid panel, HgA1C, and urinalysis. A urine pregnancy test will be performed on women of childbearing age. Testing Visit 1: MRI, IV in common femoral vein with phlebotomy (60 cc total) before and after sphygmomanometric cuff occlusion of lower limb, 6-minute walk test, 4-meter walk speed test, walking impairment questionnaire, and muscle biopsy. Supervised exercise and leg revascularization patients will return in 12 weeks and have the same study procedures as testing visit 1, plus an ankle brachial index, repeated.

Sponsors & Collaborators

Principal Investigators

  • Joshua Beckman, MD · Vanderbilt University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2023-08-22
Completion
2023-08-22

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03490968 on ClinicalTrials.gov