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临床试验/CTRI/2025/04/084420
CTRI/2025/04/084420尚未招募不适用

Impact of COVID-19 on body composition analysis in young adults

ICMR STS1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年4月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
126
试验地点
1
主要终点
Extracellular water (ECW) and total body weight (TBW) will be measured using differential impedance at 50 kHz and 200 kHz, respectively. Subsequently, intracellular water (ICW) will be obtained by deduction of ECW from TBW. Body fat (in kg) and lean body mass (in kg): These parameters will also be expressed as percentages—body fat % and lean %. Fat-Free Mass Index (FFMI) Body Fat Mass Index (BFMI) will be derived from manufacturer-programmed predictive equations. In the analysis, hydration fractions obtained from regression equations will be used to calculate lean body mass (LBW) from total body weight (TBW). Fat mass will then be determined by the difference between TBW and LBW.

研究概览

简要总结

This is a prospective, observational, cross-sectional studyto compare body composition changes between COVID-19 survivors and non-infected individuals in the young adult population. To determine the prevalence and patterns of body composition changes in young adults following COVID-19 infections. The outcome measure will be Extracellular Water (ECW) and total body weight (TBW) will be measured using differential impedance at 50 kHz and 200 kHz, respectively. Subsequently, intracellular water (ICW) will be obtained by deduction of ECW from TBW. Body Fat (in kg) and Lean Body Mass (in kg): These parameters will also be expressed as percentages—Body Fat % and Lean %. Fat-Free Mass Index (FFMI) and Body Fat Mass Index (BFMI) will be derived from manufacturer-programmed predictive equations. In the analysis, hydration fractions obtained from regression equations will be used to calculate lean body mass (LBM) from total body weight (TBW). Fat mass will then be determined by the difference between TBW and LBM.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria: Participants from the general population having knowledge of English and aged between 18 and 30 years.
  • COVID-19 group: History of COVID-19 infection confirmed by RT-PCR or antigens test at least 1 year prior to the study will be included.
  • The control group will consist of age-matched individuals who did not have any signs or symptoms of COVID-19 and were not infected by COVID-19.

排除标准

  • Active COVID-19 symptoms, autonomic imbalance, cardiovascular diseases, previously diagnosed neuropsychological disorders, or a history of severe COVID-related hospitalization.

结局指标

主要结局

Extracellular water (ECW) and total body weight (TBW) will be measured using differential impedance at 50 kHz and 200 kHz, respectively. Subsequently, intracellular water (ICW) will be obtained by deduction of ECW from TBW. Body fat (in kg) and lean body mass (in kg): These parameters will also be expressed as percentages—body fat % and lean %. Fat-Free Mass Index (FFMI) Body Fat Mass Index (BFMI) will be derived from manufacturer-programmed predictive equations. In the analysis, hydration fractions obtained from regression equations will be used to calculate lean body mass (LBW) from total body weight (TBW). Fat mass will then be determined by the difference between TBW and LBW.

时间窗: one year from 01-10-2024 to 01-10-2025

次要结局

  • Extracellular water (ECW) and total body weight (TBW) will be measured using differential impedance at 50 kHz and 200 kHz, respectively. Subsequently, intracellular water (ICW) will be obtained by deduction of ECW from TBW. Body fat (in kg) and lean body mass (in kg): These parameters will also be expressed as percentages—body fat % and lean %. Fat-Free Mass Index (FFMI) Body Fat Mass Index (BFMI) will be derived from manufacturer-programmed predictive equations. In the analysis, hydration fractions obtained from regression equations will be used to calculate lean body mass (LBW) from total body weight (TBW). Fat mass will then be determined by the difference between TBW and LBW.(one year from 01-10-2024 to 01-10-2025)

研究者

发起方
ICMR STS
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Ms Tanvi Taya

Third year Mbbs student Kasturba medical college Manipal, MAHE Manipal Karnataka india

研究点 (1)

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