Actively Recruiting

Phase Not Applicable
Age: 6Years - 65Years
All Genders
Healthy Volunteers
NCT06869590

Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis

Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-03-13

250

Participants Needed

1

Research Sites

172 weeks

Total Duration

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AI-Summary

What this Trial Is About

Anorexia nervosa (AN) is a psychiatric disorder belonging to the eating disorders (EDs). It is internationally recognized as a priority for improving health care. Among the markers of severity of undernutrition is hepatic cytolysis. Around 30-50% of patients with AN present with hepatic cytolysis, of variable intensity, and usually associated with severe undernutrition. In a previous study, we demonstrated the presence of autoantibodies against HIF1alpha (Hypoxic inducible Factor 1 alpha) in 22% of cases in a sample of patients with AN. HIF1alpha (HIF1a) is a major transcription factor involved in the regulation of satiety and hunger. These autoantibodies were positive in 80% of AN patients with hepatic cytolysis. Taken together, these data led us to hypothesize an anti-HIF1a autoimmune mechanism in AN, potentially involved in the patients' hepatic cytolysis. This pioneering study, demonstrating the existence of anti-HIF1a autoantibodies, was carried out on a population of 18 patients with AN. To extend investigator's hypothesis, these results need to be confirmed on a larger number of patients, thus increasing the number of patients with AN and hepatic cytolysis. To determine the relevance of these autoantibodies in AN, "healthy" subjects and patients without AN but with hepatic cytolysis should be tested in parallel. Finally, the in vitro pathogenic potential of autoantibodies can be confirmed on a larger scale and studied in greater detail. The main aim of our study is to evaluate the association between the presence of anti-HIF1a autoantibodies (AAHIF) and that of hepatic cytolysis in patients with anorexia nervosa and undernutrition. This study is a prospective, cross-sectional, descriptive, multicenter, 2-arm study. 250 patients will be included. Experimental group (n=100) * Patients with anorexia nervosa and undernutrition with hepatic cytolysis (CH) (n=70) * Patients with anorexia nervosa and undernutrition without hepatic cytolysis (n=30) Comparator control groups (n=150) * Control patients under 18 years of age, treated at the CHU de la Timone for scheduled non-inflammatory surgery (orthopedic, ENT, etc.) (n=50): Minor patients * Patients (children and adults) with hepatic cytolysis without anorexia nervosa (n=50): Patients without AN with CH * Samples from French blood donation establishment: control group consisting of biological blood samples from healthy individuals from the Etablissement Français du Sang (n=50)

CONDITIONS

Official Title

Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis

Who Can Participate

Age: 6Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 6 to 65 years
  • Diagnosed with anorexia nervosa according to DSM-5 criteria
  • Presence of undernutrition according to HAS 2019 criteria
  • Provided informed consent after receiving study information
  • Covered by a social security scheme
  • For control group minors: male or female under 18 years
  • Undergoing scheduled non-inflammatory surgery (orthopedic, ENT, etc.)
  • Provided informed consent
  • Covered by a social security scheme
  • For control group adults with hepatic cytolysis: male or female aged 18 to 65 years
  • Hepatic cytolysis confirmed by ALT at least twice the normal value
  • Provided informed consent
  • Covered by a social security scheme
  • No specific criteria for biological samples from blood donors
Not Eligible

You will not qualify if you...

  • Currently participating in another research protocol at time of consent
  • Patient or legal guardian refuses participation
  • Psychiatric disorder preventing consent
  • Unable to understand French language
  • Minors, adults under guardianship, patients deprived of liberty, pregnant or breastfeeding women as per French Public Health Code

AI-Screening

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Trial Site Locations

Total: 1 location

1

Assistance Publique Hopitaux De Marseille

Marseille, France, 13005

Actively Recruiting

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Research Team

N

Nathalie Bardin, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis | DecenTrialz