RecruitingPhase 3NCT05132439

MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

Metformin BenefIts Lower Extremities With Intermittent Claudication (MOBILE_IC)


Sponsor

VA Office of Research and Development

Enrollment

200 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 35 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Metformin ER and a drug called placebo for people with intermittent claudication. The study is currently recruiting participants at 1 location. People eligible for this study include aged 35 Years to 89 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin ER

Oral medication typically used for Type 2 diabetes with presumed anti-inflammatory properties

DRUGplacebo

Matched to active study drug


Locations(1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

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NCT05132439


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