- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01472679
Body Composition: a Predictor of Mortality in Subjects Over 65 Years
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Geneva, Switzerland, 1211
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Mortality from 1 January 1990 to 31 December 2011
|
Report if the subject died or not until 31st December 2011
|
Mortality from 1 January 1990 to 31 December 2011
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurence Genton, MD, University Hospital, Geneva
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11-161R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on External Causes of Morbidity and Mortality
-
Pontificia Universidad Catolica de ChileCompletedExternal Causes of Morbidity and Mortality | External Causes of Morbidity (V00-Y99)
-
Loyola UniversityCompletedExternal Causes of Morbidity and MortalityUnited States
-
Tata Main HospitalCompleted
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalUnknownExternal Causes of Morbidity and Mortality | Complications; Cesarean Section | Failure of Cervical Dilatation | Wound Infection,Turkey
-
Aga Khan UniversityAga Khan Health Services; Aga Khan Foundation, Pakistan; Centre for Global Child... and other collaboratorsTerminatedExternal Causes of Morbidity and Mortality | Stillbirth | Neonatal DeathPakistan
-
Ruhr University of BochumCompletedExternal Causes of Morbidity and MortalityGermany
-
Prince of Songkla UniversityTerminatedHypoglycemia | Nosocomial Infection | External Causes of Morbidity and MortalityThailand
-
Azienda Ospedaliero Universitaria Maggiore della...UnknownMyocardial Infarction | External Causes of Morbidity and Mortality | Fracture of Stent of Coronary Artery | Coronary Vessel DisordersItaly
-
Royal College of Anesthesiologists of ThailandChulalongkorn University; Khon Kaen University; Ramathibodi Hospital; Prince of... and other collaboratorsCompletedCritical Illness | Complications of Surgical and Medical Care: General Terms | Adverse Reaction to Drug | Sequelae of External Causes of Morbidity and MortalityThailand
-
West China HospitalUnknownQuality of Life | Gastric Cancer | Surgery | Blood Loss, Surgical | External Causes of Morbidity and Mortality | Ultrasonic Scalpel | Monopolar Electrocautery | Operation TimeChina