NCT02089971已完成不适用
Muscle Mass and Function in Chinese Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 412
- 试验地点
- 2
- 主要终点
- Total skeletal muscle mass
研究概览
简要总结
To describe the normal range of muscle mass and function in Chinese adults.
详细描述
The study objective is to setup a normal range of muscle mass and function in Chinese adults.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adult ages between 25 and 34 years, inclusively.
- •Adult is judged to be in good health as determined from his/her medical history as his/her self-report to the enrolling center personnel and as confirmed through a clinical examination by a physician.
- •Adult with BMI between 18.5 to 26.
- •Male or non-pregnant non-lactating female. Non-pregnant should be confirmed by urine pregnant test. And non-lactating is defined as postpartum more than 18 months.
- •Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
排除标准
- •Subject who is heavy manual labor.
- •Subject who is professional or semi-professional athlete or game player.
- •Subject who is physical disabilities, such as loss of hand or foot or limbs or any physical disability which may affect the physical activities and affect the distribution of muscle mass by the opinion of the study physician.
- •Subject has known chronic diseases such as endocrine system diseases (including type 1 or type 2 diabetes mellitus, or hyperthyroidism or hypothyroidism), cardiovascular diseases, liver diseases, and renal diseases as self-report.
- •Subject who has active infection of TB, HIV and hepatitis as self-report.
- •Subject who currently experiencing diarrhea or anorexia within 7days prior to the enrollment.
- •Subject who has or plans for intensive physical activities 3 days prior to the scheduled BIA measurement.
- •Subject who is thyroid malfunction (as serum fT4 level and/or serum TSH level out of the reference range of the lab)
- •Subject has implanted electronic device, orthopedic metal implantations, such as pacemaker, cardiac defibrillator, or metal hip, metal knee joint, metal fracture internal fixation, etc.
- •Subject is drug addiction or alcohol addiction.
- •Subject is anemia (as blood hemoglobin level less than 120 g/L in males and 110 g/L in females).
- •Subject is malnourished by study physician's opinion
- •Subject has active cancers as self-report
- •Subject has lost or gained more than 5% of body weight in the past 3 months
- •Subject attends other clinical trials and is not approved by AN
结局指标
主要结局
Total skeletal muscle mass
时间窗: Test Visit 1 (~ Day 13)
Dual X-ray Absorptiometry (DXA)
次要结局
- Total skeletal muscle mass(Test Visit 1 (~ Day 13))
- Total body fat free mass(Test Visit 1 (~ Day 13))
- Total body fat(Test Visit 1 (~ Day 13))
研究者
研究点 (2)
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