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临床试验/NCT03334032
NCT03334032已完成不适用

Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa

Charite University, Berlin, Germany0 个研究点目标入组 154 人开始时间: 2004年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
主要终点
Change in Total Body protein

研究概览

简要总结

The study aimed to assess protein accretion during weight gain in adolescent patients with Anorexia nervosa

详细描述

Background: Bone health and growth during adolescence require adequate Total Body Protein (TBPr). Re-nutrition for patients with anorexia nervosa (AN) should aim to normalize body composition, i.e. recovery of fat mass and TBPr.

Objective

The study intended to analyze predictors of protein status, including exercise status, in adolescents with AN, and to investigate whether weight gain would replete body protein deficits.

Methods: The investigators assessed TBPr in a longitudinal, observational study as height-adjusted nitrogen index (NI) using in-vivo neutron activation analysis in adolescents with AN at the commencement of refeeding (T0), as well as seven months thereafter (T1), and in age-matched normal weight controls. Lean tissue and fat mass were assessed with Dual-Energy X-Ray Absorptiometry (DXA). BMI, BMI-SDS and lean tissue mass were tested as predictors of protein status using Receiver Operating Characteristic (ROC) analysis.

研究设计

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

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosis of anorexia nervosa (DSM-IV)
  • aged 12 - 19 years
  • female gender

排除标准

  • existence of a further disease with effect on body composition
  • no known disease
  • normal weight

结局指标

主要结局

Change in Total Body protein

时间窗: Between baseline (inpatient admission) and at 7 months follow-up

Change in Total Body protein

次要结局

  • Change in body weight(Between baseline (inpatient admission) and at 7 months follow-up)
  • Change in Body Mass Index(Between baseline (inpatient admission) and at 7 months follow-up)
  • Change in body fat mass(Between baseline (inpatient admission) and at 7 months follow-up)
  • Change in body lean tissue mass(Between baseline (inpatient admission) and at 7 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Verena Haas

Principle Investigator, Clinical Researcher

Charite University, Berlin, Germany

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