Health TrialsbyHealthPanel

MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

ConditionIntermittent Claudication
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age35-89
SponsorVA Office of Research and Development

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Metformin ER

    Drug

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

  • placebo

    Drug

    Matched to active study drug

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Metformin ER 1000mgExperimental treatment 1 intervention
Group B: Matching placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximal Walking distance on the 6 minute walk test

This validated measure of functional status in PAD and IC is highly reproducible and the ideal measure of real-life walking capacity

Time frame
6 month

Secondary outcomes

1

6 minute walk test

This validated measure of functional status in PAD and IC is highly reproducible and the ideal measure of real-life walking capacity. The six minute walk test includes maximal walking distance, pain free walking distance, time to pain onset.

Time frame
6 month
2

6 minute walk test

This validated measure of functional status in PAD and IC is highly reproducible and the ideal measure of real-life walking capacity. The six minute walk test includes maximal walking distance, pain free walking distance, time to pain onset.

Time frame
12 month
3

Cardiopulmonary exercise test

The CPET is a well validated, reproducible measure symptom-limited (maximal) aerobic and anaerobic capacity in patients with PAD and IC and correlates with systemic disease severity and outcome

Time frame
6 month
4

Cardiopulmonary exercise test

The CPET is a well validated, reproducible measure symptom-limited (maximal) aerobic and anaerobic capacity in patients with PAD and IC and correlates with systemic disease severity and outcome

Time frame
12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

University of Pittsburgh

Collaborator

Northwestern University

Collaborator

San Francisco Veterans Affairs Medical Center

Collaborator

Source ClinicalTrials.gov
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