RecruitingPhase 4ACTRN12618001186246

Metformin for treating peripheral artery disease-related walking impairment


Sponsor

James Cook University

Enrollment

250 participants

Start Date

Jun 21, 2019

Study Type

Interventional

Conditions

Summary

This parallel group, blinded, placebo-controlled randomised trial will determine whether 1500mg/day of metformin administered for 6 months improves walking ability in PAD patients. Based on sample size calculations focused on the minimal clinically important difference, 250 PAD patients that do not have diabetes, renal or cardiac failure will be included. The trial will employ an independently run minimisation randomisation system and identical appearance, weight and packaging of drug and placebo to ensure blinding of investigations, patients and assessors, along with balancing of important determinants of outcome. The primary outcome measure will be the 6-month maximum walking distance during a six minute walk test. Secondary outcomes will include physical activity assessed over 7 days with an accelerometer, health-related quality of life, leg blood supply assessed with ankle-brachial pressure index and circulating concentrations of key markers of angiogenesis. Adverse events will be monitored by an independent data monitoring committee. Previous trials indicate metformin is safe for patients without diabetes.


Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is for people with peripheral artery disease (PAD) — a condition where the arteries supplying blood to the legs become narrowed or blocked, causing painful cramping or tightening in the legs during walking (called intermittent claudication). PAD affects quality of life significantly, as even short walks can become painful. This study tests whether metformin — a medication widely used for type 2 diabetes — can improve walking ability in people with PAD who do not have diabetes. Researchers believe metformin may improve blood vessel function and help grow new small blood vessels in the legs. Participants are randomly assigned to take either 1500mg of metformin per day or a placebo for 6 months. Walking ability is tested with a six-minute walk test. Secondary outcomes include physical activity levels, quality of life, and blood markers of blood vessel health. You may be eligible if you are aged 40 or older, have been diagnosed with PAD by a vascular specialist, experience walking limitations due to leg cramps (claudication), do not have diabetes, and do not have serious kidney or heart problems. People with severe PAD (rest pain or gangrene), previous major leg amputation, or who are currently in an exercise program for PAD are not eligible.

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

Study Design: Parallel group, blinded, placebo-controlled randomised clinical trial. Intervention - metformin: up to one 500mg capsule three times per day (1500mg/day). Titration (1-6 weeks): P

Study Design: Parallel group, blinded, placebo-controlled randomised clinical trial. Intervention - metformin: up to one 500mg capsule three times per day (1500mg/day). Titration (1-6 weeks): Participants in both arms will have their medications up titrated over 6 weeks to tolerance based on symptoms. Week 1 & 2: one 500mg capsule once per day with food (~500mg/day). Week 3 & 4: one 500mg capsule twice per day with food (~1000mg/day). Week 5 & 6: one 500mg capsule three times per day with food (~1500mg/day). Follow-up (24 weeks post titration period): participants will continue to take the maximum tolerated dose of drug up to 1500mg/day for 24 weeks. Week 7-30: one 500mg capsule three times per day with food (~1500mg/day). Participants will be given a calendar diary to keep track of the dose to be taken each week and to record the number and time of day the capsules are taken. The purpose of the diary is to assist the participant in taking the right amount of drug at the right time and day. Participants will be asked to return any empty bottles and remaining capsules to the study coordinator for a pill count in order to assess adherence.


Locations(3)

The Townsville Hospital - Douglas

NSW,QLD, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD, Australia

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ACTRN12618001186246


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