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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

Study acronym: HIAM
StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 24, 2025 to Feb 2, 2026 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Nov 24, 2025 to Feb 2, 2026
    • Site details revised
  2. Minor Primary completion date: May 1, 2027 to May 24, 2027 Completion date: Nov 1, 2028 to May 24, 2029 · Start date: Nov 1, 2025 to Nov 24, 2025v3 Show 2 more changesShow less
    • Completion date: Nov 1, 2028 to May 24, 2029
    • Start date: Nov 1, 2025 to Nov 24, 2025
  3. Notable Primary completion date: Sep 1, 2026 to May 1, 2027 Start date: Sep 1, 2025 to Nov 1, 2025 · Completion date: Sep 1, 2028 to Nov 1, 2028v2 Show 2 more changesShow less
    • Start date: Sep 1, 2025 to Nov 1, 2025
    • Completion date: Sep 1, 2028 to Nov 1, 2028
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT06869590
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Hepatic Cytolysis
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov