Status:
TERMINATED
The Effects of Metformin on Functional Capacity in Individuals With Peripheral Artery Disease-Related Intermittent Claudication
Lead Sponsor:
Baker Heart and Diabetes Institute
Conditions:
Peripheral Arterial Disease
Intermittent Claudication
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Background and Rationale: Metformin has demonstrable efficacy in slowing or reversing the progression of various insulin-resistant disease states - most notably type 2 diabetes and pre-diabetes. In s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01799057
Start Date
July 1 2013
End Date
December 1 2014
Last Update
February 9 2016
Active Locations (1)
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1
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004