NCT03490968

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-05-22
• Primary completion: 2023-08-22
• Completion: 2023-08-22
• First posted: 2018-04-06
• Last updated: 2024-02-29

Locations

1 site across 1 country: United States