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The Effects of Metformin on Functional Capacity in Individuals With Peripheral Artery Disease-Related Intermittent Claudication

NCT01799057 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-02-09

No results posted yet for this study

Summary

The purpose of this study is to determine the effects of metformin on functional capacity (pain-free and maximum walking times) in individuals with peripheral artery disease (PAD)-related intermittent claudication.

Conditions

  • Peripheral Arterial Disease
  • Intermittent Claudication

Interventions

DRUG

Metformin

Participants randomized to metformin will be treated at a maximum dose of 2000mg per day (i.e. 1000mg twice daily for 16-18 weeks; up-titrated from 500mg twice daily for the first 2 weeks). Participants may complete the 16-18 week treatment intervention at the lower dose of 500mg twice daily if limited by side effects.

DRUG

Placebo

Participants randomized to placebo will take matching oral capsules according to the same dose schedule specified for the metformin intervention.

Sponsors & Collaborators

  • Baker Heart and Diabetes Institute

    lead OTHER

Principal Investigators

  • Bronwyn A Kingwell, PhD · Baker Heart and Diabetes Institute

  • Stephen J Duffy, MD, PhD · Baker Heart and Diabetes Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01799057 on ClinicalTrials.gov