Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
Completed · Not applicable · Has a placebo group
Conditions studied: Peripheral Arterial Disease, Peripheral Artery Disease
In brief
Peripheral artery disease (PAD) is a common cardiovascular disease, in which narrowed arteries reduce blood flow to the limbs, causing pain, immobility and in some cases amputation or death. PAD patients have shown higher levels of systemic and skeletal muscle inflammation due to the impaired oxygen transfer capacity of these blood vessels. This attenuated oxygen transfer capacity causes hypoxic conditions in the skeletal muscle and results in mitochondrial dysfunction and elevated reactive oxygen species (ROS). These harmful byproducts of cell metabolism are the major cause of intermittent claudication, defined as pain in the legs that results in significant functional limitations. One potential defensive mechanism to these negative consequences may be having higher antioxidant capacity, which would improve blood vessel vasodilatory function, enabling more blood to transfer to the skeletal muscles. Therefore, the purpose of this project is to examine the impact of mitochondrial targeted antioxidant (MitoQ) intake on oxygen transfer capacity of blood vessels, skeletal muscle mitochondrial function, leg function, and claudication in participants with PAD. Blood vessel oxygen transfer capacity in the leg will be assessed in the femoral and popliteal arteries. Skeletal muscle mitochondrial function and ROS levels will be analyzed in human skeletal muscle via near infrared spectroscopy and through blood samples. Leg function will be assessed by walking on a force platform embedded treadmill and claudication times will be assessed with the Gardner maximal walking distance treadmill test.
Key facts
- Study ID
- NCT03506633
- Run by
- University of Nebraska
- People needed
- 14
- Starts
- 2018-09-05
- Expected to finish
- 2022-01-17
- Last updated by the study team
- 2025-04-01
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able to give written, informed consent
- Demonstrated positive history of chronic claudication
- History of exercise limiting claudication
- Ankle/brachial index < 0.90 at rest
- Stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks prior to study entry
- 50-85 years old
You may not qualify if…
- Resting pain or tissue loss due to Peripheral artery disease (PAD), Fontaine stage III and IV
- Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
- Walking capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology
Where it is running
- University of Nebraska - Omaha — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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