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临床试验/NCT01472679
NCT01472679已完成不适用

Body Composition: a Predictor of Mortality in Subjects Over 65 Years

Genton Graf Laurence1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2016年10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
入组人数
6,000
试验地点
1
主要终点
Mortality

研究概览

简要总结

The purpose of this study is to evaluate whether body composition is associated with a higher risk of mortality in subjects ≥ 65 years.

详细描述

Study centre: University Hospitals of Geneva Study type: retrospective study Study duration (anticipated): 1 year for collection of data(1.10.2011-1.12.2012)and 3 months for statistical analysis and writing, leading to the completion of the study by march 2013 Study hypothesis: A low fat-free mass (FFM) and a high fat mass (FM) are associated with a higher risk of mortality in subjects ≥ 65 years.

Aims: The primary objective is to evaluate the relationship between body composition and mortality in men and women ≥ 65 years, while taking into account co-morbidities. The secondary objectives are to compare this relationship a) with the relationship of body mass index (BMI) and mortality, b) with the relationship of body composition changes and mortality, c) between healthy subjects and subgroups of patients with chronic diseases Methods: Included are all subjects who had a measurement of body composition by bioelectrical impedance analyses, performed in the HUG from 1990 until december 2011. Excluded are subjects living abroad. Body composition measurements will be retrieved from DPI and 4D which preceded the use of DPI in nutrition and is presently only used for research. Diseases and specific laboratory values at time of body composition measurement will be retrieved simultaneously. Mortality will be retrieved from the population registers for death.

Statistics: The relationship between body composition and mortality, in the total population and subgroups of patients with chronic diseases, will be evaluated by Cox regression, adjusted for age, gender and co-morbidities. The variance of mortality (adjusted R2) related to FFM will be compared to that related to BMI and FFM loss.

研究设计

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

入排标准

年龄范围
65 Years 至 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects ≥ 65 years included in previous studies on body composition by bioelectrical impedance analysis performed in the Nutrition Unit since 1990 until December
  • All patients ≥ 65 years who had a measurement of body composition by bioelectrical impedance analysis performed in clinical routine by the Nutrition Unit and the dietitians of the University Hospital of Geneva since 1990 until December 2011, while hospitalized or not.

排除标准

  • Subjects living in another country than Switzerland at time of body composition measurement

结局指标

主要结局

Mortality

时间窗: Mortality from 1 January 1990 to 31 December 2011

Report if the subject died or not until 31st December 2011

次要结局

未报告次要终点

研究者

发起方
Genton Graf Laurence
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Genton Graf Laurence

Principal investigator

University Hospital, Geneva

研究点 (1)

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