Generation of Prediction Equations to Analyze Body Composition of Obese 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
- 38
- 试验地点
- 1
- 主要终点
- BIA 50 kHz
研究概览
简要总结
The study was based on the clinical trial BCA-01 (NCT01368640) "Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" and implicates an extension of the study collective. Aim of the study is 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.
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
- 否
入选标准
- •healthy adults in an
- •age range of 18 to 65 years
- •BMI > 30 kg/m2
排除标准
- •acute and chronic diseases
- •regular intake of medications (except for contraceptives)
- •amputation of limbs
- •electrical implant as cardiac pacemaker
- •insulin pumps
- •artificial joints
- •metallic implants (except tooth implants)
- •claustrophobia
- •pregnancy or breastfeeding period
- •probands who cannot provide an ICF by themselves
- •probands who might be dependent from the sponsor or the inv. site
- •current alcohol abuse
- •frequent hypersensitivity reactions/allergies determ. anamnestically
- •extensive tattoos at arms or legs
结局指标
主要结局
BIA 50 kHz
时间窗: 15 minutes
Bioelectrical Impedance of 50 kHz for all 4 extremities
Extracellular water
时间窗: 15 minutes
Extracellular water (ECW) by NaBr dilution
Total body water
时间窗: 15 minutes
Total body water (TBW) by deuterium (D2O) dilution
Skeletal muscle mass
时间窗: 1 hour
Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)
Visceral adipose tissue
时间窗: 1 hour
Visceral adipose tissue VAT by magnetic resonance imaging (MRI)
BIA 5 and 50 kHz
时间窗: 15 minutes
Bioelectrical Impedance of 5 and 50 kHz for one body side
Fat-free mass
时间窗: 1 hour
Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight
次要结局
- Complete BIA(15 minutes)