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临床试验/NCT05627583
NCT05627583已完成不适用

Τhe Effect of Nutritional rEhabilitation in Patients With Anorexia Nervosa on Markers Associated With Disease severiTy

Harokopio University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Increase in Body Weight

研究概览

简要总结

The design of this project is a longitudinal trial in patients with Anorexia Nervosa (AN) during in-hospital rehabilitation. Τhe structure of the study, the questionnaires and data protection policy prepared exclusively for our study, have been reviewed and standardised at Institutional Review Boards (Ethics Committees, IRBs,) in Harokopio University of Athens (HUA), Eginition Hospital (EH), Attiko Hospital (AH) and Sismanoglio Hospital (SG).

AN is a psychiatric disorder followed by a psychopathologic concerning of body image and very low body weight due to extreme self-starvation. The exact pathogenesis of AN remains unknown with neurobiological, gastrointestinal, neuroendocrinological, immunological, and genetic factors suspected to be implicated. Furthermore, many metabolic traits, biochemical, biological or/and anthropometrical, are manifested during the maintaining effort of patients to achieve lower body weight. Self-inflicted starvation is the primary and essential causation of the pathological outcomes of the disorder. These outcomes involve all biological systems and organs. The role of the immune system in AN is critical as levels of pro-inflammatory cytokines are increased and the immune system is dysregulated. Other contributors to AN pathogenesis have been proposed, such as increased oxidative stress, dysbiosis of the gut microbiota and altered metabolomic profiles. Treatment options for patients with AN constitutes outpatient and inpatient care accordingly with the severity of the disorder. So far, no biomarker has been strongly proposed as an indicator of the disorder's severity or for assessing the progression of the treatment.

The purpose of this study is to assess and monitor the nutritional rehabilitation of patients with AN during hospitalization treatment. Throughout the treatment's course, nutrition and feeding process, vital signs, psychopathology and biological samples will be gathered and statistical analysis of these data is expected to reveal potential biomarker/s for monitoring the progression of recovery.

详细描述

Inpatients with AN and non-eating disorders control subjects will be informed about the project outline, objectives and inclusion criteria.

Monitoring of AN patients will take place during in-hospital rehabilitation. Physical exam, lab tests, bioelectrical impedance analysis and psychometric evaluation will take place twice a month. Plasma and serum will be collected and isolated form blood samples, while stool samples will be collected for Nuclear Magnetic Resonance (NMR) metabolomics analysis and in StoolFix tubes for DNA isolation from intestinal microbiota. For serum and plasma isolation, whole blood will be directly and properly drawn into a vacutainer tube and promptly centrifuged. Then, samples will be stored at -80C until further elaboration. Case record forms will be carefully checked for missing data and inconsistencies prior to developing a proper database based on data entry. The highest ethical standards and data protection will be considered.

Assessment will include Medical history, Anthropometric measurements, Vital signs, Nutrition, Subjective Global Assessment-Patient Generated (SGA-PG), Biochemical parameters, Appetite hormones, Inflammation markers, Oxidative stress markers, Composition of intestinal microbiota, Psychometric scales-measurements, Eating Attitude Test-26 (EAT-26), Eating Disorder Examination Questionnaire (EDE-Q), Spielberger State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Body Appreciation Scale (BAS), Sense of Coherence Scale (SOC), Visual Analogue Scale (VAS) for subjective appetite estimation

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

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

  • Patients with Anorexia Nervosa according to the DSM-V (American Psychiatric Association, 2013)
  • Exclusion criteria:
  • Antibiotic treatment before and during the study

排除标准

  • 未提供

结局指标

主要结局

Increase in Body Weight

时间窗: Up to three months during inpatient rehabilitation

Increase in body weight as a marker of rehabilitation

次要结局

  • Changes in blood metals and metalloids(Up to three months during inpatient rehabilitation)
  • Changes in IL-6 levels(Up to three months during inpatient rehabilitation)
  • Changes in serum oxidisability(Up to three months during inpatient rehabilitation)
  • Metabolic recovery in patients with AN(Up to three months during inpatient rehabilitation)
  • Changes in ghrelin levels(Up to three months during inpatient rehabilitation)
  • Changes in leptin levels(Up to three months during inpatient rehabilitation)
  • Changes in EDE-Q(Up to three months during inpatient rehabilitation)
  • Changes in EAT-total(Up to three months during inpatient rehabilitation)

研究者

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

Andriana C. Kaliora

Prof. in Human Nutrition and Foods

Harokopio University

研究点 (1)

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