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

NCT ID: NCT01472679

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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External Causes of Morbidity and Mortality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genton Graf Laurence

OTHER

Sponsor Role lead

Responsible Party

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Genton Graf Laurence

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Laurence Genton, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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University Hospital

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 29717760 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25833973 (View on PubMed)

Other Identifiers

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11-161R

Identifier Type: -

Identifier Source: org_study_id