Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease
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|ClinicalTrials.gov Identifier: NCT01901224|
Recruitment Status : Terminated (study was not funded)
First Posted : July 17, 2013
Results First Posted : September 24, 2018
Last Update Posted : September 24, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease||Drug: Metformin 1000 mg Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Metformin 1000 mg
metformin 1000 mg twice daily: In order to avoid gastrointestinal side effects, the starting dose of metformin will be 500 mg twice daily. After one week, the dose will be increased to 1000 mg twice daily (as two 500 mg tablets twice daily). Subjects will be instructed to take medications with breakfast and with dinner.
Drug: Metformin 1000 mg
Placebo Comparator: Control
placebo twice daily: In order to maintain blinding during the titration period, individuals randomized to placebo will receive one placebo tablet twice daily for one week, followed by an increase to 2 placebo tablets twice daily. Subjects will be instructed to take medications with breakfast and with dinner.
- Change in PCr Recovery Time [ Time Frame: baseline, 12 weeks ]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.
- Change in Flow-mediated Dilation (FMD) [ Time Frame: baseline, 12 weeks ]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.
- Change in Maximal Treadmill Walking Time [ Time Frame: baseline, 12 weeks ]Maximal treadmill walking time is measured in minutes or seconds. Higher values indicate a better outcome.
- Change in Pain-free Treadmill Walking Time [ Time Frame: baseline, 12 weeks ]Pain-free treadmill walking time is measured in minutes or seconds. Higher values indicate a better outcome.
- Change in Oxygen Consumption [ Time Frame: baseline, 12 weeks ]Oxygen consumption is measured in ml/kg/min. Higher values indicate better outcomes.
- Change in Six Minute Walk Test [ Time Frame: baseline, 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901224
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Mark A Creager, MD||Brigham and Women's Hospital|