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Search / Trial NCT06869590

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

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Mar 5, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a specific type of autoantibody, called anti-HIF1alpha autoantibodies, in patients with anorexia nervosa (AN) who are experiencing liver cell damage (known as hepatic cytolysis). The researchers want to understand if these autoantibodies play a role in the liver problems seen in some patients with AN, particularly those who are severely undernourished. The study will include 250 participants, including 100 patients with AN and liver issues, as well as control groups of children and adults without AN but who have liver damage.

To join the study, participants must be between 6 and 65 years old, have a diagnosis of anorexia nervosa, and show signs of undernutrition. Those in the control groups will either be children undergoing surgery or adults with liver issues but without anorexia. Throughout the study, participants will provide blood samples, and all information will be gathered to better understand the connection between these autoantibodies and liver health in people with anorexia. This research aims to clarify the potential effects of these autoantibodies, which could lead to better care for individuals with AN in the future.

Gender

ALL

Eligibility 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).

About Assistance Publique Hopitaux De Marseille

Assistance Publique - Hôpitaux de Marseille (AP-HM) is a leading public healthcare institution in France, dedicated to providing high-quality medical care and advancing research in various clinical fields. As a prominent sponsor of clinical trials, AP-HM is committed to fostering innovation and improving patient outcomes through rigorous scientific investigation. With a multidisciplinary approach, the institution collaborates with a network of healthcare professionals, researchers, and academic partners to facilitate cutting-edge studies that address critical health challenges. AP-HM's dedication to ethical standards and patient safety underscores its role as a trusted leader in clinical research and healthcare delivery.

Locations

Marseille, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported