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
  Purpose

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


Condition
External Causes of Morbidity and Mortality

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Body Composition: a Predictor of Mortality in Subjects Over 65 Years

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 4500
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472679

Locations
Switzerland
University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
Genton Graf Laurence
Investigators
Principal Investigator: Laurence Genton, MD University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Genton Graf Laurence, Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01472679     History of Changes
Other Study ID Numbers: 11-161R
Study First Received: November 7, 2011
Last Updated: March 10, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
fat mass
fat free mass
body mass index

ClinicalTrials.gov processed this record on October 01, 2014