Anti-HIF1alpha antibodies and their role in liver cell damage in people with anorexia nervosa
Official title: Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
Run by Assistance Publique Hopitaux De Marseille · NCT06869590 · Data updated 2026-11-12
It tests whether people with anorexia nervosa have anti-HIF1alpha antibodies that are linked to liver cell damage during severe undernutrition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 65 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | May 24, 2027 |
| Study ends | May 24, 2029 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT06869590 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Assistance Publique Hopitaux De Marseille
Marseille, France Recruiting
Study contacts
- Study coordinator: Nathalie Bardin, Pr
- Email: Nathalie.BARDIN@ap-hm.fr
- Phone: 0491435817
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.