Body Composition: a Predictor of Mortality in Subjects Over 65 Years
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|ClinicalTrials.gov Identifier: NCT01472679|
Recruitment Status : Active, not recruiting
First Posted : November 16, 2011
Last Update Posted : May 3, 2018
|Condition or disease|
|External Causes of Morbidity and Mortality|
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.
|Study Type :||Observational|
|Estimated Enrollment :||4500 participants|
|Official Title:||Body Composition: a Predictor of Mortality in Subjects Over 65 Years|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2019|
- Mortality [ Time Frame: Mortality from 1 January 1990 to 31 December 2011 ]Report if the subject died or not until 31st December 2011
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472679
|Geneva, Switzerland, 1211|
|Principal Investigator:||Laurence Genton, MD||University Hospital, Geneva|