Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 992
- 试验地点
- 1
- 主要终点
- Bioelectrical Impedance of 1, 1.5, 2, 3, 5, 7.5, 10, 15, 20, 30, 50, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz
研究概览
简要总结
The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI and FFMI is based on the results of two other clinical investigations: "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" (BCA-01) and "Application and adaption of device specific body composition formulas to various ethnic groups" (BCA-02). The aim of BCA-01 was to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand. The equations are necessary to use the device as a Body Composition Analyzer with an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to apply and adapt device specific body composition formulas to various ethnic groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited. All subjects need to be suitable for blood donation according to "Hämotherapie-Richtlinie nach §§ 12a und 18 TFG", chapter 2.1.4 "Untersuchung zur Eignung als Spender und zur Feststellung der Spendertauglichkeit".
排除标准
- •amputation of limbs
- •electrical implant as cardiac pacemaker
- •insulin pumps
- •probands who cannot provide an ICF by themselves
- •probands who might be dependent from the sponsor or the inv. site
- •extensive tattoos at arms or legs
结局指标
主要结局
Bioelectrical Impedance of 1, 1.5, 2, 3, 5, 7.5, 10, 15, 20, 30, 50, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz
时间窗: about 15 minutes
The measurement is planned to be done for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side. In total resistance and reactance at 19 frequencies for 7 body segments are planned to be measured.
次要结局
- Verification of equivalence to a predicate device in accordance to Premarket Notification [510(k)] process of the FDA for product approval in the U. S.(about 15 minutes)