The PERMET trial will determine whether metformin daily for six months improves six-minute walk performance in individuals with peripheral artery disease compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
University of Florida
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
Six-minute Walk Performance
Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
Time frame: Change from baseline to six-month follow-up
Maximal Treadmill Walking Time
A Gardner treadmill exercise protocol will be used
Time frame: Change from baseline to six-month follow-up
Brachial Artery Flow-mediated Dilation
Upper brachial artery flow-mediated dilation was evaluated by measuring percent change in the brachial artery diameter in response to reactive hyperemia, induced by inflating a blood pressure cuff for five minutes over the brachial artery.
Time frame: Percent change from baseline to six-month follow-up
The Walking Impairment Questionnaire - Distance Score
The Walking impairment questionnaire is a patient reported outcome measure, in which participants indicate the ease of walking distances ranging from across the room to up to approximately 1500 feet. The score is calculated on a 0-100 scale, where 0 indicates the in ability to walk any of the distances and 100 indicates no difficulty walking any of the distances.
Time frame: Change from baseline to six-month follow-up
The SF-36 Physical Functioning Score
This outcome is a patient reported quality of life measure. The score ranges from 0 to 100, where 0 indicates extremely poor functioning and 100 indicates the best possible functioning,
Time frame: Change from baseline to six-month follow-up
Calf Muscle Biopsy Biochemical Measures - Capillary Density
Capillary density was measured as the number of capillaries per mm2 of muscle.
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Ochsner Medical Center
New Orleans, Louisiana, United States
Time frame: Change from baseline to six-month follow-up