Impact of Statin Therapy on Adaptations to Aerobic Exercise
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Difference in Mitochondrial Respiratory Function
研究概览
简要总结
The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.
详细描述
High cholesterol and cardiovascular disease (CVD) is currently prevented and treated with statin therapy. Statin use can cause muscle weakness, fatigue and/or pain, and these symptoms can increase with dose and duration of statin use. Statins may also change the ability to exercise.
This study is testing how different doses of a statin, Lipitor, affect muscle health and exercise. The doses that will be used in this study (20 mg/day or 80 mg/day) are typical for treating high cholesterol.
This study is expected to last about 14 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 25-43 kg^m2
- •Sedentary (less than 150 min of physical activity/week during last 6 months)
- •Weight stable (no more than 5% change in body weight the previous 3 months)
- •>5% risk for a cardiovascular event in the next 10 years according to the 2013 American College of Cardiology/American Heart Association risk calculator and/or 2 out of 5 metabolic syndrome risk factors(Triglycerides ≥ 150 mg/dL; HDL ≤ 40 mg/dL; Glucose ≥ 100mg/dL; Waist Circumference ≥ 102cm for males, 88cm for females; Blood pressure: ≥ 130mmHg systolic and/or 85mmHg diastolic or being treated for hypertension).
- •Stable doses of medications for 90 days
- •Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy
排除标准
- •Use of statins in the last 6 months
- •Use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil)
- •Diagnosis of chronic diseases including CVD, diabetes, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
- •History of abnormal bleeding problems
- •Currently taking (within the last 10 days) anti-platelet medication (Plavix), Warfarin, and other anti-coagulants (eliquis, pradaxa, and xarelto) medications
- •>2 fold upper normal limit (UNL) for alanine aminotransferase (ALT) or creatinine
- •Women who are pregnant or breastfeeding
- •Individuals with polymorphisms known to be associated with susceptibility for statin induced myopathies (tested at screening)
- •Currently enrolled in another research study
研究组 & 干预措施
Placebo & Exercise Group
Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.
干预措施: Placebo (Drug)
Placebo & Exercise Group
Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.
干预措施: Exercise Program (Behavioral)
Low Statin & Exercise Group
Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.
干预措施: Lipitor 20Mg Tablet (Drug)
Low Statin & Exercise Group
Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.
干预措施: Exercise Program (Behavioral)
High Statin & Exercise Group
Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.
干预措施: Lipitor 80Mg Tablet (Drug)
High Statin & Exercise Group
Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.
干预措施: Exercise Program (Behavioral)
结局指标
主要结局
Difference in Mitochondrial Respiratory Function
时间窗: Value at 3 months minus value at baseline
次要结局
- Change in VO2 Max(Value at 12 months minus value at baseline)