About this trial
Peripheral arterial disease (PAD) affects over 20% of aged adults and is very common among Veterans due significant tobacco use. PAD is due to the progressive blockage of peripheral arteries, predominantly to the legs, and results in intermittent claudication (IC) or recurrent muscle pain with activity secondary to insufficient blood supply. Those with PAD and IC experience a progressive decline in walking and poor quality of life. There is no effective medical treatment for PAD and IC. Metformin is a safe and effective treatment for Type 2 diabetes but it can also reduce inflammation, oxidative stress, and improve energy requirements as well as improve blood flow to the legs. Therefore, the investigators will test the ability of Metformin to improve overall functional status, reduce PAD progression, and reduce systemic inflammation in Veterans suffering from PAD and IC in a randomized, placebo controlled trial: Metformin BenefIts Lower Extremities with Intermittent Claudication (MOBILE IC) Trial. The success of this trial may identify a safe and effective treatment for PAD and IC.
Eligibility criteria
Qualifiers
Male and Female Veteran >35 & <89
Symptoms of Intermittent claudication
Medically stable, optimal medical therapy (for >3 months prior to randomization which includes - statin and anti-platelet therapy, blood pressure control, smoking cessation and physical activity counseling)
PAD as defined by ABI <0.9 or >0.9 with evidence of PAD as documented by pulse volume recordings (within 6 months prior to expected randomization date)
Disqualifiers
Diabetes (Type I or II) or Hemoglobin A1c>6.5 (within 6 months of expected randomization)
Currently Taking metformin or have previously taken metformin (within 6 months of enrollment)
Medical condition that limit their ability to ambulate other than PAD (i.e., Angina, CHF, pulmonary disease requiring oxygen, malignancy requiring treatment, etc.)
Prior above or below knee amputation
Trial design
Treatments tested in this trial
- Metformin ER
- placebo
Treatment groups
Sponsors and collaborators
VA Office of Research and Development
Lead sponsor
University of Pittsburgh
Collaborator
Northwestern University
Collaborator
San Francisco Veterans Affairs Medical Center
Collaborator