Status:
RECRUITING
Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.
Lead Sponsor:
University of Roma La Sapienza
Collaborating Sponsors:
University of Trieste
University of North Carolina, Chapel Hill
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Brief 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 ma...
Detailed Description
Assessing body composition in persons with obesity, and in particular, the excess of fat mass and the possible reduction of muscle mass, is important to define the phenotypic manifestation of obesity ...
Eligibility Criteria
Inclusion
- Adults with obesity (BMI ≥ 30 kg/m²)
- Age 18 years and older
- Available baseline DXA and BIA measurements
- Provided informed consent for data use
Exclusion
- any chronic disease or medication that can significantly affect body composition \[eg. malignant diseases in the last 5 years, organ failure, acute inflammation (C-reactive protein\>10 mg/L) autoimmune diseases, neurological diseases, syndromic obesity\]
- cognitive impairment (Mini-Mental State Examination \<25)
- subjects that are considered physically active (athletes or very active subjects i.e., performing at least 150 minutes of moderate to vigorous physical activity per week)
- alcohol intake \>140g/wk for Males and 70g/wk for Females
- participation in a weight-reducing program (last 3 months)
- impossibility to perform DXA exam
- pregnancy and breast-feeding.
Key Trial Info
Start Date :
May 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06545435
Start Date
May 13 2021
End Date
December 31 2025
Last Update
August 26 2024
Active Locations (9)
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1
Pennington Biomedical Research Center, Louisiana State University
Baton Rouge, Louisiana, United States, 70808
2
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, United States, 27514
3
Curtin University, School of Population Health
Perth, Australia, 6102
4
Federal University of Pelotas
Pelotas, Rio Grande do Sul, Brazil, 96010-610