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临床试验/NCT06545435
NCT06545435招募中不适用

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

University of Roma La Sapienza9 个研究点 分布在 6 个国家目标入组 400 人开始时间: 2021年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
9
主要终点
Development and Cross-Validation of BIA Equations for Appendicular Soft Tissue Masses

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: Baseline

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.

次要结局

  • Algorithm Development for Conversion Between BIA Devices(Baseline)
  • Comparison of New BIA Equations with Existing Models(Baseline)
  • Cross-Validation of New BIA Equations with Different DXA Systems(Baseline)
  • Validation of BIA Equations Using Magnetic Resonance Imaging (MRI)(Baseline)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Donini Lorenzo M

Full Professor

University of Roma La Sapienza

研究点 (9)

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