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临床试验/NCT06800742
NCT06800742招募中不适用

Body Composition, Resting Energy Expenditure and Physical Activity in Adolescents With Anorexia Nervosa

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Fat-free mass

研究概览

简要总结

Body Mass Index (BMI) is currently the most widely recommended parameter for identifying underweight subjects. Among eating disorder diseases, anorexia nervosa (AN) is the one with the highest mortality rate and with relapses between 12 and 27%. To date, recovery programs allow approximately 40% of subjects to achieve recovery, 30% demonstrate improvements, and 20% remain chronically affected. These data demonstrate the importance of continuously monitoring changes in weight and body composition of these subjects. Bioelectrical impedance (BIA) is widely used to determine body composition in AN. BIA provides various parameters, such as lean mass (LM), fat mass (FM), total body water (TBW), and phase angle (PhA). Among these parameters, in addition to LM and FM, PhA has also been used to characterize underweight subjects with AN. In addition to the observed relationship between PhA and body composition in individuals with AN, PhA has also been related to the basal metabolic rate (BMR). BMR undergoes changes mainly due to loss of muscle mass and a significant reduction in BMR has been observed in AN subjects. Finally, physical activity represents a significant determinant of body composition and can help regulate BMR.

Therefore, monitoring changes in body composition (LM, FM, and PhA) and indirect indices (lean mass index and fat mass index) using BIA, together with monitoring changes in BMR and physical activity level, could provide important support for the continuous control and definition of the clinical stage of the disease in patients with AN.

The aim of this study is to determine body composition, basal metabolic rate, and level of physical activity in Anorexia Nervosa and normal weight subjects to identify the most consistent parameters to define the clinical stage of the disease in subjects with AN.

详细描述

Body Mass Index (BMI) is currently the most widely recommended parameter for identifying underweight subjects. Among eating disorder diseases, anorexia nervosa (AN) is the one with the highest mortality rate and with relapses between 12 and 27%. To date, recovery programs allow approximately 40% of subjects to achieve recovery, 30% demonstrate improvements, and 20% remain chronically affected. These data demonstrate the importance of continuously monitoring changes in weight and body composition of these subjects. Bioelectrical impedance (BIA) is widely used to determine body composition in AN. BIA provides various parameters, such as lean mass (LM), fat mass (FM), total body water (TBW), and phase angle (PhA). Among these parameters, in addition to LM and FM, PhA has also been used to characterize underweight subjects with AN. In addition to the observed relationship between PhA and body composition in individuals with AN, PhA has also been related to the basal metabolic rate (BMR). BMR undergoes changes mainly due to loss of muscle mass and a significant reduction in BMR has been observed in AN subjects. Finally, physical activity represents a significant determinant of body composition and can help regulate BMR.

Therefore, monitoring changes in body composition (LM, FM, and PhA) and indirect indices (lean mass index and fat mass index) using BIA, together with monitoring changes in BMR and physical activity level, could provide important support for the continuous control and definition of the clinical stage of the disease in patients with AN.

The aim of this study is to determine body composition, basal metabolic rate, and level of physical activity in Anorexia Nervosa and normal weight subjects to identify the most consistent parameters to define the clinical stage of the disease in subjects with AN.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Adolescents with Anorexia Nervosa:
  • •Inclusion Criteria:
  • •Female sex
  • •Age range: 12-18 years
  • •Anorexia nervosa
  • •Hospitalized at the Division of Auxologia, San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy

排除标准

  • •Absence of signed informed consent
  • •Adolescents with normal weight:
  • •Inclusion Criteria:
  • •Female sex
  • •Age range: 12-18 years
  • •Normal weight
  • •Exclusion Criteria:
  • •Absence of signed informed consent

研究组 & 干预措施

Anorexia Nervosa (AN)

Female adolescents with Anorexia Nervosa

干预措施: Collection of anthropometric and biochemical parameters (Other)

Normal weight

Female normal weight adolescents

干预措施: Collection of anthropometric and biochemical parameters (Other)

结局指标

主要结局

Fat-free mass

时间窗: Baseline

Fat-free mass as assessed by bioelectrical impedance

Basal Metabolic Rate

时间窗: Baseline

Basal Metabolic Rate as calculated

Fat mass

时间窗: Baseline

Fat mass as assessed by bioelectrical impedance

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Body Composition in Adolescents With Anorexia Nervosa | 临床试验