Anti-HIF1alpha antibodies and their role in liver cell damage in people with anorexia nervosa
Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
It tests whether people with anorexia nervosa have anti-HIF1alpha antibodies that are linked to liver cell damage during severe undernutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 6 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06869590 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls people aged 6–65 with DSM-5 anorexia nervosa and undernutrition, plus two control groups (minors having non-inflammatory surgery and adults without anorexia who have ALT ≥2× normal). Blood samples are collected at enrollment and again after 3–4 months to detect anti-HIF1alpha autoantibodies and to relate antibody presence to hepatic cytolysis. The protocol aims to characterize whether these autoantibodies have pathogenic potential contributing to liver cell injury in undernourished patients. The work follows up on a small prior finding that detected anti-HIF1alpha antibodies in 22% of patients and in 80% of those with hepatic cytolysis.
Who should consider this trial
Good fit: Ideal participants are people aged 6–65 with DSM-5 anorexia nervosa and undernutrition per HAS criteria who can provide informed consent and attend blood draw visits, with controls drawn from minors scheduled for non-inflammatory surgery and adults without anorexia who have ALT ≥2× normal.
Not a fit: Patients without anorexia, without notable liver enzyme elevation, or those unable to complete baseline and 3–4 month blood sampling are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If confirmed, identifying anti-HIF1alpha antibodies could help explain and predict liver damage in anorexia nervosa and guide earlier or more targeted clinical care.
How similar studies have performed: This approach is novel: a single small prior study (n=18) reported anti-HIF1alpha autoantibodies in 22% of anorexia patients and in 80% of those with hepatic cytolysis, but larger confirmation is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Experimental group: * Male or female, 6 to 65 years of age * Anorexia nervosa diagnosed according to DSM-5 criteria * Presence of undernutrition according to HAS 2019 criteria * Patient having received information about the study and having signed an informed consent form * Beneficiary or beneficiary of a social security scheme Control group: * Minor patients : * Male or female strictly under 18 years of age * Patients undergoing scheduled non-inflammatory surgery (orthopedic, ENT, etc.) * Patients who have been informed about the study and have signed an informed consent form. * Patients who are beneficiaries or entitled beneficiaries of a social security scheme. * Patients without anorexia with livers cytolysis : * Male or female between 18 and 65 years of age * With hepatic cytolysis determined by an ALT value at least equal to twice the normal value * Patient having received information about the study and having signed an informed consent form * Patient who is a beneficiary or eligible beneficiary of a social security scheme. * samples Etablissement Français de don de sang: no specific criteria Exclusion Criteria: * Patient in a period of exclusion from another research protocol at the time consent is signed. * Opposition of patient and parents or legal guardians * Psychiatric disorder preventing patient consent to study * Person unable to understand the French language * Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women).
Where this trial is running
Marseille
- Assistance Publique Hopitaux De Marseille — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Nathalie Bardin, Pr
- Email: promotion.interne@ap-hm.fr
- Phone: 0491435817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.