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临床试验/NCT02635958
NCT02635958已完成不适用

Validation of the InBody 770® for the Assessment of Body Composition

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2015年12月最近更新:
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
176
试验地点
1
主要终点
Body Composition Measures

研究概览

简要总结

With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically quite pertinent to accurately assess a patients' body fat percentage, fat free mass, and total body water and changes that are occurring with nutritional support.

详细描述

This study will use a stratified design. Eligible participants will be categorized with BMI category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1 of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥ 35. Within these arms, the 44 participants will participate in an InBody 770® body composition measure as well as an iDXA body composition measure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

入选标准

  • Between 18 and 65 years of age
  • Have a Body Mass Index ≥ 18.5 kg/m2

排除标准

  • Are not English speaking
  • Are younger than 18 years of age
  • Weigh more than 450 lbs
  • Taller than 6'6" due to size constraints of the iDXA
  • Have a pacemaker, defibrillator, artificial lung, artificial heart, electrocardiograph, or nerve simulator
  • People having radioactive iodine thyroid treatment.
  • People who have had a nuclear medicine study or a barium X-ray within the last 5 days.
  • People with large amounts of metal in their bodies.
  • People with arthritis of the spine recorded in the medical record.
  • Are pregnant

结局指标

主要结局

Body Composition Measures

时间窗: 1 day

compare body composition measures between InBody and iDXA

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan T. Hurt, M.D., Ph.D.

PI

Mayo Clinic

研究点 (1)

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