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Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.

Status: Recruiting
Location: See all (9) locations...
Study Type: Observational
SUMMARY

This study aims to develop and cross-validate novel bioelectrical impedance analysis (BIA) equations for predicting appendicular soft tissue masses, specifically fat mass (FM) and appendicular lean mass (ALM), in a sample of Caucasian adult subjects affected by obesity. The research will compare these new BIA equations with three established BIA-derived prediction models and validate them using dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI) data. This study utilizes existing datasets to enhance the accuracy and applicability of BIA in assessing body composition and supports the development of standardized algorithms for converting raw BIA data across different devices and populations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults with obesity (BMI ≥ 30 kg/m²)

• Age 18 years and older

• Available baseline DXA and BIA measurements

• Provided informed consent for data use

Locations
United States
Louisiana
Pennington Biomedical Research Center, Louisiana State University
RECRUITING
Baton Rouge
North Carolina
Division of Geriatric Medicine, School of Medicine, and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Other Locations
Australia
Curtin University, School of Population Health
RECRUITING
Perth
Brazil
Federal University of Pelotas
RECRUITING
Pelotas
Canada
University of Alberta, Department of Agricultural, Food and Nutritional Science
RECRUITING
Edmonton
Italy
University of Cagliari, Department of Life and Environmental Sciences
RECRUITING
Cagliari
Sapienza, University of Rome
RECRUITING
Roma
Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy
RECRUITING
Trieste
Portugal
Universidade de Lisboa, Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana
RECRUITING
Lisbon
Contact Information
Primary
Lorenzo M Donini, MD
lorenzomaria.donini@uniroma1.it
00390649690215
Backup
Eleonora Poggiogalle, Md, PhD
eleonora.poggiogalle@uniroma1.it
00390649690215
Time Frame
Start Date: 2021-05-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 400
Treatments
Obese Adults Cohort
This cohort includes Caucasian adult subjects with obesity (BMI ≥ 30 kg/m²). Participants have undergone baseline assessments using both Dual X-ray Absorptiometry (DXA) and Bioelectrical Impedance Analysis (BIA).
MRI Validation Subset
A subset of participants from the Obese Adults Cohort selected for additional validation using Magnetic Resonance Imaging (MRI) to assess muscle size and architecture.
Related Therapeutic Areas
Sponsors
Leads: University of Roma La Sapienza
Collaborators: University of Cagliari, Curtin University, University of Trieste, University of Lisbon, Federal University of Pelotas, University of Alberta, Louisiana State University Health Sciences Center in New Orleans, University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov