Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.
Part of paid clinical trials in Baton Rouge, Louisiana.
- Sponsor
- University of Roma La Sapienza
- Study ID
- NCT06545435
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- May 13, 2021
- Status verified
- Aug 2024
- Primary completion
- Jun 30, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 400 participants (estimated)
Arms
- Arm: Obese Adults CohortThis 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).
- Arm: MRI Validation SubsetA subset of participants from the Obese Adults Cohort selected for additional validation using Magnetic Resonance Imaging (MRI) to assess muscle size and architecture.
Primary Outcome Measure
Development and Cross-Validation of BIA Equations for Appendicular Soft Tissue Masses [ Time Frame: Baseline ]
Central Contacts
- Lorenzo M Donini, MD00390649690215
- Eleonora Poggiogalle, Md, PhD00390649690215
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pennington Biomedical Research Center, Louisiana State University | Baton Rouge | Louisiana | 70808 | Steven Heymsfield |
| Division of Geriatric Medicine, School of Medicine, and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | John A Batsis |
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