Clinical trial NCT03510533: Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders
Official title: Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorder
Keywords: autoantibodies (autoAc) circulating
neuropeptides (Ghrelin, l'α-MSH)
potential digestive origin
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eating disorders compared to healthy volonteers
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patients with eating disorders

1. 18 Years and older
2. first clinical visit in nutrition department of CHU de Rouen for eating disorders
3. anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V
4. social security Affiliation
5. Patient who signed the MEC approved informed consent

Volunteers

1. 18 Years to 60 Years
2. body mass index ≥ 18,5 kg/m2 and ≤ 24,9 kg/m2
3. negative SCOFF test
4. No active and history of eating disorders
5. social security Affiliation
6. volunteer who signed the MEC approved informed consent

Exclusion criteria:

Patients with eating disorders

1. No anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V
2. Adults under legal protection or under safeguard of justice or administrative decision
3. Pregnancy

Volunteers

1. Active or history of eating disorder
2. Adults under legal protection or under safeguard of justice or administrative decision
3. Pregnancy

Primary outcomes:
measure: 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
timeFrame: 1 week
Secondary outcomes:
measure: Scale for determination factors associated with eating disorders
timeFrame: 1 week
measure: statute in autoantibody and behavioral characteristics of the eating disorder
timeFrame: 1 week
measure: Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders
timeFrame: 1 week
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre d'Investigation Clinique
Study officials:
affiliation: University Hospital, Rouen
name: Najate EL MACHKOURI ACHAMRAH, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: