MetfOrmin BenefIts Lower Extremities with Intermittent Claudication (MOBILE IC): randomized clinical trial protocol

Area of Science:

• Vascular Medicine
• Pharmacology
• Exercise Physiology

Background:

• Peripheral artery disease (PAD) affects over 230 million globally, characterized by atherosclerosis, inflammation, and hypertension.
• Intermittent claudication (IC) is a common symptom of PAD, leading to mobility loss and increased cardiovascular risk.
• Current treatments for PAD and IC are limited, necessitating novel therapeutic approaches.

Purpose of the Study:

• To evaluate the efficacy of metformin in improving functional status in non-diabetic patients with IC.
• To assess metformin's impact on PAD progression, systemic inflammation, and mitochondrial function.
• To determine the effect of metformin on cardiovascular events and quality of life in PAD patients.

Main Methods:

• A randomized, placebo-controlled trial involving 200 non-diabetic Veterans with IC.
• Participants received 1000 mg/day of metformin extended-release or placebo for 180 days.
• Primary outcome: change in 6-minute walk test (6MWT) distance; secondary outcomes included functional assessments, inflammatory markers, and cardiovascular events.

Main Results:

• The study is designed to assess the primary outcome of 180-day maximum walking distance on the 6-minute walk test (6MWT).
• Secondary outcomes encompass functional status, quality of life, lower extremity blood flow, and cardiovascular events.
• Systemic inflammation markers and mitochondrial function will also be evaluated throughout the study.

Conclusions:

• Metformin's anti-inflammatory and promitochondrial properties suggest potential benefits for PAD and IC.
• The MOBILE IC trial aims to provide evidence for metformin as a novel therapeutic option for non-diabetic PAD patients.
• Findings could lead to improved management strategies for PAD, enhancing patient mobility and cardiovascular health.