Clinical trial NCT06545435: Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.
Official title: Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: Appendicular Lean Mass
Fat Mass
Body Composition
Bio-Impedance Analysis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: University of Trieste
name: University of North Carolina, Chapel Hill
name: Federal University of Pelotas
name: Louisiana State University Health Sciences Center in New Orleans
name: University of Cagliari
name: University of Lisbon
name: University of Alberta
name: Curtin University
First posted: 2024-08-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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 (estimating the risk of dysmetabolic, cardiovascular, and functional complications), and to determine a better treatment approach. Dual X-ray absorptiometry (DXA) is a mature technology for assessing body composition with major advances in the technology over the past three decades. DXA is a validated tool to investigate body composition phenotypes, as it reliably assesses whole-body and regional bone mineral content, fat mass and lean mass. Unfortunately, it is not always available in all settings where instead Bio-Impedance Analysis (BIA) (which has lower costs and greater convenience of use) is commonly used to estimate body composition starting from electrical resistance and reactance data.

Regrettably, the two methods often give non-superimposable results and studies have been carried out to predict, from BIA, values commonly obtainable only with DXA. In particular, different studies estimated the appendicular lean mass from BIA, which represents an important parameter for the evaluation of sarcopenia and is correlated with its functional limitations. For example, a post hoc analysis of the PROVIDE study was aimed in particular at assessing the level of agreement between BIA- and DXA-derived soft tissue ratios as indicators of limb tissue quality and at developing and cross-validating new BIA equations for predicting appendicular soft tissue \[fat mass (FM) and appendicular lean mass (ALM)\] in older Caucasian adults with physical function decline using both the Hologic Horizon and GE Lunar DXA systems as reference methods.

METHODS:

This study is based on baseline data (anthropometric, BIA, and DXA) collected in pre-existing datasets. In particular

* the Sapienza dataset which derived from a study aimed at investigating the association between markers of insulin sensitivity and SO defined by three novel body composition models will be used to develop BIA equations predicting appendicular soft tissue masses;
* datasets from different studies and in particular from the BIA International Dataset Project will be used to validate the BIA equations assessing the agreement between BIA- and DXA-derived soft tissue estimation

STUDY PARAMETERS:

-Anthropometry: anthropometric parameters should have been measured in accordance with validated and standardized methodologies.

The anthropometric parameters of interest are body mass, stature, waist circumference, calf circumference, arm circumference, and triceps skinfold thickness, limb length.

-Dual energy X-ray absorptiometry: all participants should have been scanned using a fan beam whole body DXA device (Hologic Bedford, Massachusetts, USA; Lunar Prodigy, GE Healthcare). Daily calibration of the densitometers should have been performed following the instructions provided by the manufacturer.

Since measurements vary among instruments from different manufacturers, calibration equations will be used to address these issues and improve the agreement between devices.

The body components of interest are total fat mass (FM), total lean mass (LM), ALM (sum of the lean mass in the limbs), FM (sum of the fat mass in the limbs), and the ratio of ALM to FM.

-Bioelectrical impedance analysis: After overnight fasting and bladder voiding, bioelectrical impedance analysis should have been performed with participants lying supine (with their limbs slightly away from their body; active electrodes should have been placed on the right side on conventional metacarpal and metatarsal lines, recording electrodes in standard positions at the right wrist and ankle) or in vertical position (barefoot, stepping onto the electrodes embedded into the scale and grasping the electrode-embedded handles). At each location, a whole-body tetrapolar BIA device operating at a weak alternating electrical current of 500 µA to 1 mA and a single frequency of 50 kHz should have been used to measure the voltage drop across body tissues.

The electric parameters of interest are resistance (R: restriction of current flow), reactance (Xc: capacitance of cell membranes and tissue interfaces), and phase angle (PhA).

The information about BIA devices will be recorded since raw R and Xc values may not be not comparable.

Due to the significant differences found in different studies when comparing vertical to supine position, the results obtained with the two methodologies will be analysed separately.

With reference to the limitation reported by the PROVIDE study authors (i.e. the absence of a direct measurement of extracellular water), the raw data detected through multifrequency bioimpedance devices will also be used, where available. Specifically, the values of impedance and resistance measured at a frequency of 5 kHz will be included; furthermore, where available, it would be optimal to analyze data measured at the following frequencies; 1, 2, 5, 10, 50, 100, 200, 250 and 500 kHz.

STATISTICS:

Data will be analyzed by using IBM® SPSS® Statistics version 25. The data will be presented as frequency (percent) and mean ± SD for qualitative and quantitative variables, respectively. The Shapiro-Wilk test will be used to evaluate if the data are normally distributed. Comparison of continuous variables will be performed using parametric or non-parametric tests depending on whether the distribution is normal or not. The chi-square test will be used to check whether the frequencies occurring in the sample differ significantly from the expected frequencies. The cut-off for statistical significance will be set at p\<0.05.

Preliminary equations, using DXA-derived appendicular lean and fat mass as the dependent variables, and age, gender, BMI, weight, impedance index, and reactance as independent variables, will be developed using a stepwise multiple linear regression approach. Only significant regressors of appendicular soft tissue masses will be considered in the equations.

Model performance fit will be assessed using multiple correlations (R2) and standard errors of the estimate (SEE). For each of the appendicular soft tissue components, the model with the lowest standard error of the estimate will be used in the cross-validation analysis.

The individual and body composition data from the cross-validation samples will be imputed into the developed equations to assess their accuracy. The statistics for cross-validation includes mean difference, limits of agreement, and root mean squared error.

Additionally, the agreement between ALM_BIA estimated in our sample, ALM_SERGI, ALM_Provide, and ALM_KYLE will be assessed using regression analysis.

Finally, the agreement between the ALM/FM-ratios estimated by DXA and by BIA will be evaluated using Bland and Altman analysis.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Development and Cross-Validation of BIA Equations for Appendicular Soft Tissue Masses
timeFrame: Baseline
Secondary outcomes:
measure: Comparison of New BIA Equations with Existing Models
timeFrame: Baseline
measure: Algorithm Development for Conversion Between BIA Devices
timeFrame: Baseline
measure: Cross-Validation of New BIA Equations with Different DXA Systems
timeFrame: Baseline
measure: Validation of BIA Equations Using Magnetic Resonance Imaging (MRI)
timeFrame: Baseline
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center, Louisiana State University
state: Louisiana
city: Chapel Hill
country: United States
facility: Division of Geriatric Medicine, School of Medicine, and Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
state: North Carolina
city: Perth
country: Australia
facility: Curtin University, School of Population Health
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: Rio Grande Do Sul
city: Edmonton
country: Canada
facility: University of Alberta, Department of Agricultural, Food and Nutritional Science
state: Alberta
city: Cagliari
country: Italy
facility: University of Cagliari, Department of Life and Environmental Sciences
city: Roma
country: Italy
facility: Sapienza, University of Rome
city: Trieste
country: Italy
facility: Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy
city: Lisboa
country: Portugal
facility: Universidade de Lisboa, Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana
Study officials:
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