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Набира участници NCT06545435

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

Заболявания: Obesity

Спонсор: University of Roma La Sapienza

Налично на: БГ
Обобщение
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.
Описание
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
Кой може да участва
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.
Места на провеждане 6
Австралия (1)
Curtin University, School of Population Health
Perth
Бразилия (1)
Federal University of Pelotas
Pelotas , Rio Grande do Sul
Канада (1)
University of Alberta, Department of Agricultural, Food and Nutritional Science
Edmonton , Alberta
Италия (1)
University of Cagliari, Department of Life and Environmental Sciences
Cagliari
Португалия (1)
Universidade de Lisboa, Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana
Lisbon
САЩ (1)
Pennington Biomedical Research Center, Louisiana State University
Baton Rouge , Louisiana
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
13.05.2021
Крайна дата
31.12.2025
Регистрационен номер
NCT06545435
Източник
anzctr
Запитване за медицински туризъм

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