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

NCT03510533 | Completed

• 2 other identifiers: 2016/0107/HP2017-A00875-48
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eating Disorder

Keywords

autoantibodies (autoAc) circulating; neuropeptides (Ghrelin, l'α-MSH); potential digestive origin

Outcome Measures

Primary Outcomes (1)

• 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

  blood samples collections

  1 week

Secondary Outcomes (3)

• 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

Study Arms (2)

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

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

healthy volunteers

OTHER

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

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

Interventions

Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation OTHER

blood samples (12ml) and stool samples (30g) collections

Also known as: Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB, Factors associated with eating disorders

Eating disorders patients; healthy volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with eating disorders
• 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
• Volunteers
• 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

You may not qualify if:

• 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
• Pregnancy
• Volunteers
• Active or history of eating disorder
• Adults under legal protection or under safeguard of justice or administrative decision
• Pregnancy

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Centre d'Investigation Clinique

Rouen, 76031, France

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Ghrelin; alpha-MSH; Appetite Regulation; Endopeptidase Clp

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Pro-Opiomelanocortin; Hypothalamic Hormones; Melanocyte-Stimulating Hormones; Melanocortins; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Nerve Tissue Proteins; Proteins; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Appetite; Hunger; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; ATP-Dependent Endopeptidases; ATP-Dependent Proteases; ATPases Associated with Diverse Cellular Activities; AAA Proteins; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Adenosine Triphosphatases; Peptide Hydrolases; Endopeptidases; Carrier Proteins; Mitochondrial Proteins; Chloroplast Proteins; Plant Proteins

Study Officials

• Najate EL MACHKOURI ACHAMRAH, MD, PhD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eating disorders compared to healthy volonteers

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 27, 2018
• Study Start: May 24, 2018
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (1)