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

Not Applicable

• Conditions: Eating Disorder
• Interventions: Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation

• Registration Number: NCT03510533
• Lead Sponsor: University Hospital, Rouen

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.

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-26
• Last Update Submitted: 2018-04-26
• Study First Posted: 2018-04-27
• Last Update Posted: 2018-04-27
• Study Start: 2018-05
• Primary Completion: 2020-10
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy volunteers	Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation	Volunteers with negative SCOFF test (No active or history of eating disorders)
Eating disorders patients	Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation	first clinical visit in nutrition department of CHU de Rouen for eating disorders (anorexia nervosa, hyperphagia or bulimia) according to the classification DSM-V

Primary Outcome Measures

Name	Time	Method
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	1 week	blood samples collections

Secondary Outcome Measures

Name	Time	Method
Scale for determination factors associated with eating disorders	1 week	A global scale will evaluate : * socio demographic factors; * somatic and psychiatric comorbidities; * addictions; * personal and family antecedents; * major events
statute in autoantibody and behavioral characteristics of the eating disorder	1 week	quality of life and the psychological state of the patients tests
Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders	1 week	stoll samples collections

Trial Locations

Locations (1)

Centre d'Investigation Clinique; 🇫🇷 Rouen, France