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

NCT06545435 | Recruiting

• 1 other identifier: 0606/2021
• Study Type: observational
• Target: 400
• Locations: 6 countries
• Sites: 9

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 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.

Conditions

Obesity

Keywords

Appendicular Lean Mass; Fat Mass; Body Composition; Bio-Impedance Analysis

Outcome Measures

Primary Outcomes (1)

• Development and Cross-Validation of BIA Equations for Appendicular Soft Tissue Masses

  This primary outcome measures the accuracy and cross-validation of newly developed bioelectrical impedance analysis (BIA) equations in predicting appendicular soft tissue masses, including fat mass (FM) and appendicular lean mass (ALM), in Caucasian adults with obesity. The aim is to validate these equations against dual-energy X-ray absorptiometry (DXA) measurements.

  Baseline

Secondary Outcomes (4)

• Comparison of New BIA Equations with Existing Models

  Baseline

• Algorithm Development for Conversion Between BIA Devices

  Baseline

• Cross-Validation of New BIA Equations with Different DXA Systems

  Baseline

• Validation of BIA Equations Using Magnetic Resonance Imaging (MRI)

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of Caucasian adult subjects with obesity, specifically those who have undergone baseline body composition assessments using Dual X-ray Absorptiometry (DXA) and Bioelectrical Impedance Analysis (BIA). Participants are selected from existing datasets, including individuals with a Body Mass Index (BMI) of 30 kg/m² or higher. Eligible participants are aged 18 years and older and have provided informed consent for their data to be used in research. The population excludes those with conditions that may significantly affect body composition.

You may qualify if:

• Adults with obesity (BMI ≥ 30 kg/m²)
• Age 18 years and older
• Available baseline DXA and BIA measurements
• Provided informed consent for data use

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University of Trieste: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Federal University of Pelotas: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• University of Cagliari: collaborator
• University of Lisbon: collaborator
• University of Alberta: collaborator
• Curtin University: collaborator

Study Sites (9)

Pennington Biomedical Research Center, Louisiana State University

Baton Rouge, Louisiana, 70808, United States

RECRUITING

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, United States

RECRUITING

Curtin University, School of Population Health

Perth, 6102, Australia

RECRUITING

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96010-610, Brazil

RECRUITING

University of Alberta, Department of Agricultural, Food and Nutritional Science

Edmonton, Alberta, T6G 2P5, Canada

RECRUITING

University of Cagliari, Department of Life and Environmental Sciences

Cagliari, 09042, Italy

RECRUITING

Sapienza, University of Rome

Roma, Italy

RECRUITING

Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy

Trieste, Italy

RECRUITING

Universidade de Lisboa, Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana

Lisbon, 1495-751, Portugal

RECRUITING

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lorenzo M Donini, MD

CONTACT

00390649690215; lorenzomaria.donini@uniroma1.it

Eleonora Poggiogalle, Md, PhD

CONTACT

00390649690215; eleonora.poggiogalle@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: May 13, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

PT (1); US (2); CA (1); BR (1); IT (3); AU (1)