跳至主要内容
临床试验/NCT03510533
NCT03510533已完成不适用

Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2018年5月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
211
试验地点
1
主要终点
Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) involved in food intake regulation among patients with eating disorders

研究概览

简要总结

This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation.

详细描述

Eating disorders are a public health issue. It has been recently reported the importance of immune system modifications in eating disorders physiopathology, involving autoantibodies directed against neuropeptides regulating food intake. A recent study of laboratory INSERM 1073 showed the existence of an intestinal bacterial protein exhibiting structural similarities with α-MSH: ClpB. The autoAc directed against the latter also react with α-MSH because of these similarity of structures, thus leading to a potential digestive origin of these autoAc. To consolidate this new etiopathogenic assumption, a large clinical study is necessary with analysis of patients autoAc profiles. a monocentric study with inclusion of 240 patients over 2 years and 80 healthy volunteers is proposed.

This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation. Nutritional modulations (probiotic, amino-acid…) could constitute an interesting therapeutic perspective in the future.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with eating disorders
  • 18 Years and older
  • first clinical visit in nutrition department of CHU de Rouen for eating disorders
  • anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V
  • social security Affiliation
  • Patient who signed the MEC approved informed consent
  • 18 Years to 60 Years
  • body mass index ≥ 18,5 kg/m2 and ≤ 24,9 kg/m2
  • negative SCOFF test
  • No active and history of eating disorders
  • social security Affiliation
  • volunteer who signed the MEC approved informed consent

排除标准

  • Patients with eating disorders
  • No anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V
  • Adults under legal protection or under safeguard of justice or administrative decision
  • Active or history of eating disorder
  • Adults under legal protection or under safeguard of justice or administrative decision

研究组 & 干预措施

Eating disorders patients

Experimental

first clinical visit in nutrition department of CHU de Rouen for eating disorders (anorexia nervosa, hyperphagia or bulimia) according to the classification DSM-V

干预措施: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation (Other)

healthy volunteers

Other

Volunteers with negative SCOFF test (No active or history of eating disorders)

干预措施: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation (Other)

结局指标

主要结局

Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) involved in food intake regulation among patients with eating disorders

时间窗: 1 week

blood samples collections

次要结局

  • Scale for determination factors associated with eating disorders(1 week)
  • statute in autoantibody and behavioral characteristics of the eating disorder(1 week)
  • Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders(1 week)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验