跳至主要内容
临床试验/NCT04321317
NCT04321317已完成不适用

Accuracy of Air Displacement Plethysmography Compare to Dual X-ray Absorptiometry (DXA) in Girls With Anorexia Nervosa

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年4月19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
10
试验地点
2
主要终点
Accuracy of Air Displacement Plethysmography (ADP) for body fat mass measurement

研究概览

简要总结

Anorexia nervosa is a severe cause of undernutrition. It leads to a dramatic decrease of weight with an important modification of the body composition. During the renutrition phase, disharmonious body composition recovery is a relapse factor. Dual X-ray absorptiometry (DXA) is the gold standard to study body composition in children with anorexia nervosa. But, due to technical limits, DXA analysis needs to take in account a potential failure to thrive with an adjustment on height. Moreover DXA needs an irradiation which does not allow close repeat measurements. Since several years, a simple, non-invasive, non-irradiant method for measure of body composition has been developed in pediatrics: the air displacement plethysmography (ADP). Actually, only one device is available for this measurement: the BodPod®. However, feasibility and accuracy of ADP compare to DXA have not been evaluated in pediatric anorexia nervosa. The aim of this study is to compare the accuracy of BodPod® compare to DXA in girls with anorexia nervosa.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged between 8 and 18 years
  • Female with a diagnosis of anorexia nervosa according to the DSM V classification, restrictive type or hyperphagic / purgative access type, evolving for less than 3 years.
  • Female who received explanations adapted to their level of understanding for this study
  • Female who expressed their consent to participate to this study
  • Female whose parents or holders of parental authority have been informed and signed free and informed consent
  • Female affiliated to a social security scheme

排除标准

  • Patients with psychotic symptoms
  • Patients with claustrophobia
  • Patients with severe respiratory disease

结局指标

主要结局

Accuracy of Air Displacement Plethysmography (ADP) for body fat mass measurement

时间窗: 1 year

The accuracy of Air Displacement Plethysmography (ADP) will be compare to Dual X-ray Absorptiometry (DXA) according to the percentage of body fat mass measurement. The hypothesis will be validating if difference in percentage in body fat mass between ADP and DXA is below the 4%. The measurement will be done two times at 1 year interval

次要结局

  • Acceptability of Air Displacement Plethysmography (ADP) by the patient compared to Dual X-ray Absorptiometry (DXA)(1 year)
  • Accuracy of Air Displacement Plethysmography (ADP) compare to Bio Electrical Impedance (BEI)(1 year)
  • Longitudinal evolution of the percentage of body fat mass(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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