NCT03012139已完成不适用
Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Skeletal muscle oxidative capacity
研究概览
简要总结
This study is designed to gain a better understanding of the mechanisms leading to muscle wasting and metabolic abnormalities in skeletal muscle of cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 35-80 years
- •Diagnosis of metastatic cancer with cachexia (≥5% drop in body mass in less than 12 months), metastatic cancer without cachexia (<5% drop in body mass in 12 months) or no history of cancer but similar in age and sex as other groups.
排除标准
- •Current use of vitamin D analogs
- •Fasting plasma glucose ≥126 mg/dL
- •Renal failure (serum creatinine > 1.5mg/dl)
- •Chronic active liver disease (Bilirubin > 17mmol/L, AST>144IU/L, or ALT>165IU/L)
- •Contraindications to MRI (e.g., pacemaker, ferrous materials within body).
- •Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
- •Renal insufficiency/failure (serum creatinine > 1.5mg/dl)
- •Oral warfarin group medications or history of blood clotting disorders.
- •People who have taken Bevacizumab
- •Platelet count <100,000 per uL
- •Pregnancy or breastfeeding
- •Alcohol consumption greater than 2 glasses/day or other substance abuse
- •Untreated or uncontrolled thyroid disorders
- •Debilitating chronic disease (at the discretion of the investigators)
- •Previous injury/trauma/surgery to the region being measured without full recovery
- •Pain in the area to be assessed
- •Any medical condition affecting the ability to execute a maximal muscle contraction
- •The presence of infections, highly communicable diseases (AIDS, active tuberculosis, veneral disease, hepatitis) or metastatic bone disease that may interfere with safely executing maximal effort.
- •Significant neurological or musculoskeletal disorders or disease that may interfere with safely executing maximal contraction
- •Any congenital, developmental, or other bone disease or previous surgeries that may interfere with successful testing
结局指标
主要结局
Skeletal muscle oxidative capacity
时间窗: Approximately within a month of recruitment
Muscle oxidative capacity will be measured by magnetic resonance spectroscopy
Skeletal muscle protein synthesis
时间窗: Approximately within a month of recruitment
Muscle protein synthesis will be measured in the postabsorptive state from the rate of incorporation of isotopically labeled amino acids given intravenously.
次要结局
未报告次要终点
研究者
研究点 (1)
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