Clinical trial NCT01472679: Body Composition: a Predictor of Mortality in Subjects Over 65 Years
Official title: Body Composition: a Predictor of Mortality in Subjects Over 65 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: External Causes of Morbidity and Mortality
Keywords: fat mass
fat free mass
body mass index
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 6000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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 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

Primary outcomes:
measure: Mortality
timeFrame: Mortality from 1 January 1990 to 31 December 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Laurence Genton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graf CE, Herrmann FR, Genton L. Relation of Disease with Standardized Phase Angle among Older Patients. J Nutr Health Aging. 2018;22(5):601-607. doi: 10.1007/s12603-018-1034-4.
citation: Graf CE, Karsegard VL, Spoerri A, Makhlouf AM, Ho S, Herrmann FR, Genton L. Body composition and all-cause mortality in subjects older than 65 y. Am J Clin Nutr. 2015 Apr;101(4):760-7. doi: 10.3945/ajcn.114.102566. Epub 2015 Feb 11.