Peripheral Artery Disease Clinical Trial
Official title:
Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease
NCT number | NCT01901224 |
Other study ID # | 2013P001042 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 2013 |
Est. completion date | June 2015 |
Verified date | September 2018 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are doing this research study to find out if taking Metformin improves
walking ability in patients with peripheral arterial disease (PAD). In PAD the arteries
(blood vessels) in the legs are narrowed because of the build up of plaque. The leg muscle
can hurt in patients with PAD and this is usually described as a cramp or tiredness. This
pain is called intermittent claudication. Metformin is an FDA approved medication for the
treatment of diabetes. The investigators believe that Metformin may help your leg muscles
work better.
The investigators will enroll up to 100 subjects in order to find 60 subjects with PAD at
Brigham and Women's Hospital (BWH).
Status | Terminated |
Enrollment | 2 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Age 40 years or greater - Intermittent claudication for 6 months or greater - Maximal walk time between 1-20 minutes on all ETTs - Resting ABI = 0.9 in index leg at baseline - ABI falls = 20% in index leg 1 minute post baseline ETT - MWT variability < 20% Exclusion Criteria: - Type 1 or Type 2 Diabetes - Limb-threatening ischemia (rest pain, ulceration, gangrene) - Peripheral vascular surgery or PCI within 6 months - MI or CABG within 6 months - Carotid endarterectomy (CEA) within 6 months - Cerebrovascular accident or TIA within 6 months - Uncontrolled hypertension (SBP > 140 mmHg, DBP >90 mmHg) - Pentoxifylline/Cilostazol added/changed within 3 months - HMG-CoA reductase inhibitor added/changed within 3 months - Exercise limitations other than claudication (heart failure, angina, COPD, arthritis, neuropathy, etc.) - Serum creatinine = 1.5 mg/dL - Pregnant or plans to become pregnant - 2 hour Oral Glucose Tolerance Test (OGTT) > 200 mg/dL |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Maximal Treadmill Walking Time | Maximal treadmill walking time is measured in minutes or seconds. Higher values indicate a better outcome. | baseline, 12 weeks | |
Other | Change in Pain-free Treadmill Walking Time | Pain-free treadmill walking time is measured in minutes or seconds. Higher values indicate a better outcome. | baseline, 12 weeks | |
Other | Change in Oxygen Consumption | Oxygen consumption is measured in ml/kg/min. Higher values indicate better outcomes. | baseline, 12 weeks | |
Other | Change in Six Minute Walk Test | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.The 6 MWT is measured in meters, and higher values indicate better outcomes. | baseline, 12 weeks | |
Primary | Change in PCr Recovery Time | PCr recovery time, measured in seconds, is a measure of skeletal muscle metabolic function. PCr is a transport molecule and reservoir of high-energy phosphate bonds, which is important for cellular energetics. Phosphocreatine regeneration depends upon the skeletal muscle mitochondrial cells capacity for oxidative phosphorylation. We will measure PCr recovery time at baseline and after 12 weeks of treatment with metformin or placebo as an in vivo measure of mitochondrial function. Higher Pcr relative to P(i) during recovery is better and shorter recovery times are better. | baseline, 12 weeks | |
Secondary | Change in Flow-mediated Dilation (FMD) | Flow mediated vasodilation of the brachial artery is a measure of endothelium-dependent vasodilation. Higher flow-mediated dilation (FMD), measured as the diameter of the brachial artery in millimeters, and reported as percent change after a flow stimulus compered to basal measurement, is better, indicative of better endothelial function. | baseline, 12 weeks |
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