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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genton Graf Laurence, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01472679
First received: November 7, 2011
Last updated: March 10, 2014
Last verified: March 2014

November 7, 2011
March 10, 2014
October 2011
May 2013   (final data collection date for primary outcome measure)
Mortality [ Time Frame: Mortality from 1 January 1990 to 31 December 2011 ] [ Designated as safety issue: No ]
Report if the subject died or not until 31st December 2011
Mortality [ Time Frame: Mortality over 21years (from 1 January 1990 to 31 December 2011) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01472679 on ClinicalTrials.gov Archive Site
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Body Composition: a Predictor of Mortality in Subjects Over 65 Years
Body Composition: a Predictor of Mortality in Subjects Over 65 Years

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

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

This is a historical cohort study of prospectively collected measurements of body composition performed by bioelectrical impedance analysis, between 1990 and 2011.

External Causes of Morbidity and Mortality
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4500
December 2014
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All subjects ≥ 65 years included in previous studies on body composition by bioelectrical impedance analysis performed in the Nutrition Unit since 1990 until December 2011.
  • 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.

Exclusion Criteria:

  • Subjects living in another country than Switzerland at time of body composition measurement
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01472679
11-161R
No
Genton Graf Laurence, University Hospital, Geneva
Genton Graf Laurence
Not Provided
Principal Investigator: Laurence Genton, MD University Hospital, Geneva
University Hospital, Geneva
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP