MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Walking Impairment: maximum treadmill distance
研究概览
简要总结
In our research, we are delving into whether taking MitoQ for six months can improve the symptoms and function of people diagnosed with peripheral artery disease, especially those who suffer from leg pain while walking, known as intermittent claudication. We will be checking if MitoQ helps people with claudication walk better, be more active every day, feel better about their lives, and if it enhances the health of their leg muscles.
详细描述
This study will investigate whether taking MitoQ for six months can improve the walking ability, daily activity levels, and quality of life of people with claudication (leg pain) caused by peripheral artery disease (PAD). We'll also look at how MitoQ affects their calf muscles.
Here's what we'll be checking:
Muscle health: We'll examine muscle tissue samples under a microscope to see if MitoQ improves muscle health and function.
Body chemistry: We'll check blood tests to see if MitoQ affects overall health markers.
Mitochondrial health: We'll see if MitoQ reduces damage to mitochondria (the cell's powerhouses) and helps the body get rid of damaged ones. We'll also see if it improves how well mitochondria function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind, randomized, placebo-controlled trial with two parallel arms.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a positive history of chronic claudication
- •exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon
- •documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging
- •stable blood pressure, lipid and diabetes regimens and risk factor control for 6 weeks.
排除标准
- •rest pain or tissue loss due to PAD (Fontaine stage III and IV)
- •acute lower extremity ischemic event
- •walking capacity significantly and primarily limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology.
研究组 & 干预措施
MitoQ
Participants will be placed on a 24-week regimen of oral dosing with MitoQ. The patients will take two 20 mg caps of MitoQ on empty stomach, each morning
干预措施: Walking assessment (Diagnostic Test)
MitoQ
Participants will be placed on a 24-week regimen of oral dosing with MitoQ. The patients will take two 20 mg caps of MitoQ on empty stomach, each morning
干预措施: QOL Survey (Other)
MitoQ
Participants will be placed on a 24-week regimen of oral dosing with MitoQ. The patients will take two 20 mg caps of MitoQ on empty stomach, each morning
干预措施: Ankle pressure at rest and after stress (Diagnostic Test)
MitoQ
Participants will be placed on a 24-week regimen of oral dosing with MitoQ. The patients will take two 20 mg caps of MitoQ on empty stomach, each morning
干预措施: Muscle Oxygen (Diagnostic Test)
MitoQ
Participants will be placed on a 24-week regimen of oral dosing with MitoQ. The patients will take two 20 mg caps of MitoQ on empty stomach, each morning
干预措施: Serum MitoQ Level (Diagnostic Test)
MitoQ
Participants will be placed on a 24-week regimen of oral dosing with MitoQ. The patients will take two 20 mg caps of MitoQ on empty stomach, each morning
干预措施: Needle Biopsy (Procedure)
Placebo
The patients will take two identical caps of matched placebo on empty stomach, each morning
干预措施: Walking assessment (Diagnostic Test)
Placebo
The patients will take two identical caps of matched placebo on empty stomach, each morning
干预措施: QOL Survey (Other)
Placebo
The patients will take two identical caps of matched placebo on empty stomach, each morning
干预措施: Ankle pressure at rest and after stress (Diagnostic Test)
Placebo
The patients will take two identical caps of matched placebo on empty stomach, each morning
干预措施: Muscle Oxygen (Diagnostic Test)
Placebo
The patients will take two identical caps of matched placebo on empty stomach, each morning
干预措施: Serum MitoQ Level (Diagnostic Test)
Placebo
The patients will take two identical caps of matched placebo on empty stomach, each morning
干预措施: Needle Biopsy (Procedure)
结局指标
主要结局
Walking Impairment: maximum treadmill distance
时间窗: Before and After 6 months of treatment with MitoQ or placebo
Evaluation of maximum walking distance on treadmill until participant chooses to stop due to pain in his legs.
次要结局
- Walking Impairment: initial claudication treadmill distance(Before and after 6 months of treatment with MitoQ or placebo)
- Walking Impairment: daily physical activity(Before and after 6 months of treatment with MitoQ or placebo)
- Leg hemodynamics ankle/brachial index at rest and after stress(Before and after 6 months of treatment with MitoQ or placebo)
- Walking Impairment: 6 minute distance(Before and after 6 months of treatment with MitoQ or placebo)
- Walking Impairment Short Form-36(Before and after 6 months of treatment with MitoQ or placebo)
- Leg hemodynamics muscle heme-oxygen (StO2)(Before and after 6 months of treatment with MitoQ or placebo)
- Calf muscle cell damage(Before and after 6 months of treatment with MitoQ or placebo)
- Calf muscle inflammation(Before and after 6 months of treatment with MitoQ or placebo)
- Level of MitoQ in the blood and the muscle(After 6 months of treatment with MitoQ or placebo)
- Calf muscle fibrosis(Before and after 6 months of treatment with MitoQ or placebo)
- Calf muscle blood vessel health(Before and after 6 months of treatment with MitoQ or placebo)
- Walking Impairment Questionnaire(Before and after 6 months of treatment with MitoQ or placebo)
- Calf muscle mitochondria function and damage(Before and after 6 months of treatment with MitoQ or placebo)