NCT03351998已完成4 期
Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Difference in Mitochondrial Respiratory Function
研究概览
简要总结
The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle health and function, and cardiovascular fitness.
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
- •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) and/or LDL-Cholesterol >120 mg/dl.
- •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
- •Previous use of statins
- •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, other metabolic diseases (e.g., thyroid), current diagnosis and active treatment of cancer, HIV, or acquired immunodeficiency syndrome.
- •Diagnosis of type 1 or type 2 diabetes at the time of screening (fasting blood glucose >126mg/dL). If evidence of type 2 diabetes outcome measures is detected during the course of the study (fasting glucose > 126 mg/dl or HbA1c > 6.5%) we will notify the participant to contact their physician.
- •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 (SLCO1B1 and GATM) 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
Placebo Comparator
Participants receiving matching placebo oral tablet.
干预措施: Placebo Oral Tablet (Drug)
Low dose statin
Active Comparator
Participants will receive Lipitor 20Mg Tablet to take daily.
干预措施: Lipitor 20Mg Tablet (Drug)
High dose statin
Active Comparator
Participants will receive Lipitor 80Mg Tablet to take daily.
干预措施: Lipitor 80Mg Tablet (Drug)
结局指标
主要结局
Difference in Mitochondrial Respiratory Function
时间窗: value at 12 months minus value at baseline
次要结局
- Change in VO2 Max(value at 12 months minus value at baseline)
研究者
研究点 (2)
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