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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baker Heart and Diabetes Institute; Baker IDI Heart and Diabetes Institute
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Age ≥40 years old.

• Resting ankle-brachial index (ABI) ≤0.90 in the limiting leg(s), or a >20% reduction in the ABI measured immediately post-exercise where the resting ABI is >0.90. In cases of incompressible arteries in the limiting leg(s) (i.e. ABI ≥1.40), a toe-brachial index (TBI) of ≤0.70 is required.

• Peripheral artery stenosis/occlusion in the limiting leg(s), documented by duplex ultrasonography or other imaging tests.

• Stable (i.e. 3-month history) intermittent claudication in at least one PAD-affected leg.

• Maximum walking time during graded treadmill exercise testing (Gardner-Skinner protocol) ≥1 minute and ≤16 minutes.

• Concurrent medications that may affect primary, secondary or exploratory endpoints have remained stable over the previous 3 months.

• Have given signed informed consent to participate in the study.

Exclusion Criteria:

• Identification of any other medical condition requiring immediate therapeutic intervention.

• Clinically significant abnormal electrocardiogram (ECG) at rest or during exercise that represents a contraindication to study procedures or the study drug.

• Myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft surgery (CABG), or other major surgery within the previous 6 months.

• Exercise capacity limited by a factor other than PAD-related intermittent claudication.

• Any condition that precludes valid completion of a treadmill exercise test.

• Critical limb ischemia in either leg, defined as PAD-related chronic ischemic rest pain or skin lesions (ulcers, gangrene).

• Previous peripheral revascularisation or other surgical treatment for PAD in the previous 6 months.

• Known non-atherosclerotic cause of PAD.

• Active cancer.

• Uncontrolled hypertension (resting brachial blood pressure ≥160/100 mmHg).

• Evidence of pharmacologically-treated or poorly controlled (i.e. HbA1c ≥7.5%) type 2 diabetes or other class of diabetes (e.g. type 1 diabetes).

• Known intolerance or contraindication(s) to metformin.

• Known contraindication(s) to "Definity" (perflutren lipid microsphere).

• Participation or intention to participate in another clinical research study during the study period.

• History of non-compliance to medical regimens or unwillingness to comply with the study protocol.

• Any other condition that in the opinion of the Investigators would confound the evaluation and interpretation of the data.

• Persons directly involved in the execution of the protocol.

• Incapable of providing written informed consent due to cognitive, language, or other reasons.