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临床试验/NCT02346474
NCT02346474已完成不适用

Cross Calibration of Two Dual Energy Densitometers and Comparison of Regional Adipose Tissue Measurements by iDXA and MRI.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Comparison of body fat measurements

研究概览

简要总结

Background:

  • It is important for doctors to know how much fat a person has in his or her body. Machines called DXAs measure how much fat mass and fat-free mass a person has. Researchers in this study have a new DXA machine, and they want to know if it measures body fat as well as the old machine. They also want to see how body fat readings from the new DXA compare to readings from a magnetic resonance imaging (MRI) scan.

Objectives:

  • To see if two DXA machines give the same results when measuring body fat. Also, to know whether the DXA and MRI give the same results in measuring visceral and subcutaneous fat.

Eligibility:

  • People 18 years and older who weigh less than 350 pounds.

Design:

  • Participants will be screened with a medical history and physical exam. Women will have a pregnancy test. Researchers will make sure participants are able to have an MRI if they volunteered to.
  • Participants will have their body fat measured by each DXA scanner. They will lie quietly on a padded table while being scanned. The scan uses X-rays to take pictures of the body. Both scans will be done on the same morning and will take 10-15 minutes on both machines.
  • Some participants also will have their body fat measured with MRI. They will lie in a long, tube-shaped scanner. The machine uses strong magnetic fields and radio waves to take pictures of internal organs. Participants will sign an additional consent form for this procedure.

详细描述

Our Research unit (NIDDK) recently acquired a new x-ray unit (the General Electric (GE) Lunar iDXA) for measurement of body composition (how much fat someone has as a percent of their weight). This machine provides clearer and crisper images. The unit also has a larger table to allow patients up to 450 lbs (204 kg) to be scanned. The larger table allows for easier positioning of tall and heavy patients. We would like to use this new machine in the future but want to see whether our current DXA unit (the Lunar Prodigy Densitometer by GE) and the Lunar iDXA Densitometer (GE) measure the same percentage of a person s body fat. If there are measurement differences between the two machines, we will develop a way to convert the new results to more closely match the results from the current DXA unit. Thus, in this study, we will be asking volunteers to undergo scanning for measurement of body fat on both machines on the same day.

Fat within the belly which is around organs (called visceral fat or VAT) is linked to more bad health outcomes than fat which is just underneath the skin (called subcutanoues fat or SAT). Along with standardizing the DXA - body composition measurement results we would like to compare VAT and SAT estimates from iDXA with values obtained by MRI. The precise MRI measurements completely avoid radiation exposure for the volunteers but are far more time consuming. Knowing that the results of iDXA match up with or correlate with the MRI results would allow us to use iDXA measurements to estimate visceral and subcutaneous adipose tissue depots in ongoing and the future studies.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Comparison of body fat measurements

时间窗: 1 year

次要结局

  • Comparison of DXA and MRI visceral fat(1 year)

研究者

研究点 (1)

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