Hepatic CytolysisHIAMNCT06869590
Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
A study testing blood sampling and blood sampling after 3-4 months in people with Hepatic Cytolysis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Cytolysis
- What is being tested?
- blood sampling and blood sampling after 3-4 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2026to 24 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux De Marseille
Marseille, 13005
Nathalie Bardin, Pr, 0491435817 ext. +33, Nathalie.BARDIN@ap-hm.fr
About this study
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.
Read more
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
- Hepatic Cytolysis
- Being tested
- blood sampling, blood sampling after 3-4 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
When blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM).
blood sampling after 3-4 monthsOther
In the event of AAHIF positivity, a second sample will be taken between 12 and 16 weeks later to verify the persistence of autoantibodies: Visit 2.
| Study group | Role | What they receive |
|---|---|---|
| Patient with anorexia nervosa and anti-HIF1a autoantibody positivity | Experimental | When blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. In the event of AAHIF positivity, a second sample will be taken between 12 and 16 weeks later to verify the persistence of autoantibodies: Visit 2. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM). Receives: Other: blood sampling; Other: blood sampling after 3-4 months |
| Patient with anorexia nervosa and no anti-HIF1a autoantibody positivity | Experimental | When blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM). Receives: Other: blood sampling |
| Patient without anorexia nervosa and anti-HIF1a autoantibody positivity | Active comparator | When blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. In the event of AAHIF positivity, a second sample will be taken between 12 and 16 weeks later to verify the persistence of autoantibodies: Visit 2. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM). Receives: Other: blood sampling; Other: blood sampling after 3-4 months |
| Patient without anorexia nervosa and no anti-HIF1a autoantibody positivity | Active comparator | When blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM). Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of anti-HIF1a autoantibodies (AAHIF) in comparison with the presence of hepatic cytolysis in patients with anorexia nervosa and undernutrition
Comparison of the prevalence of anti-HIF1a autoantibodies (AAHIF) in patients with AM according to the presence or absence of hepatic cytolysis.
Measured: From enrollment to the end of study at 36 months
Secondary outcomes (5)
Rate of AAHIF in a population of healthy subjects
Measured: From enrollment to the end of the study at 36 months
Rate of AAHIF in patients without anorexia nervosa and with hepatic cytolysis.
Measured: From enrollment to the end of the study at 36 months
Rate of AAHIF in patients with anorexia nervosa and suffering from malnutrition
Measured: From enrollment to the end of the study at 36 months
Rate of AAHIF according to clinico-biological criteria for AOS identified in routine care
age, sex, type of AN (pure or mixed restrictive, restrictive and hyperphagic/purgative), duration of disorders, attitudes and behaviors related to AN (assessed by the Eating Disorder Inventory 2 EDI 2 questionnaire), weight, BMI, weight loss in 1 month, weight loss in 6 months or since onset of illness, severity of undernutrition, presence of problematic physical hyperactivity (assessed by the Exercise Dependence Scale-Revised EDSR questionnaire), presence of amenorrhea, use of enteral nutrition, associated treatments, leukocytes, neutrophils, lymphocytes, hemoglobin, platelets, creatinine, urea, AST, ALT, GGT, fasting blood glucose, PT, albumin, pre-albumin (transthyretin), vitamin B12, folate, vitamin D, ferritin.
Measured: From enrollment to the end of the study at 36 months
Pathogenic potential in vitro of AAHIF in hepatic cytolysis
Functional effects of the purified AAHIF fraction on hepatocyte cell lysis and its impact on HIF1a-dependent signaling.
Measured: From enrollment to the end of the study at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start2 Feb 2026
- Primary completion24 May 2027 (estimated)
- Study completion24 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CytolysisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869590
- Sponsor's protocol ID
- RCAPHM24_0497
- Other IDs
- 2025-A00018-41
- Acronym
- HIAM
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
- ClinicalTrials.gov ID
- NCT06869590
- Acronym / sponsor ID
- HIAM / RCAPHM24_0497
- Conditions
- Hepatic Cytolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 24 May 2027 (estimated)
- Study completion
- 24 May 2029 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient with anorexia nervosa and anti-HIF1a autoantibody positivity | Experimental | Other: blood sampling, Other: blood sampling after 3-4 monthsWhen blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. In the event of AAHIF positivity, a second sample will be taken between 12 and 16 weeks later to verify the persistence of autoantibodies: Visit 2. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM). |
| Patient with anorexia nervosa and no anti-HIF1a autoantibody positivity | Experimental | Other: blood samplingWhen blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM). |
| Patient without anorexia nervosa and anti-HIF1a autoantibody positivity | Active comparator | Other: blood sampling, Other: blood sampling after 3-4 monthsWhen blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. In the event of AAHIF positivity, a second sample will be taken between 12 and 16 weeks later to verify the persistence of autoantibodies: Visit 2. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM). |
| Patient without anorexia nervosa and no anti-HIF1a autoantibody positivity | Active comparator | Other: blood samplingWhen blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM). |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingWhen blood is drawn as part of the treatment, three additional dry tubes will be taken for the immunology laboratory (see study diagram). These three dry tubes will be used to test for 1/ anti-nuclear autoantibodies and those associated with hepatic autoimmune pathologies 2/ AAHIF and assess their pathogenic potential using techniques already developed. The third dry tube will be sent to the Biogénopole Biological Resource Center (CHU Timone, APHM). | Other | Patient with anorexia nervosa and anti-HIF1a autoantibody positivity, Patient with anorexia nervosa and no anti-HIF1a autoantibody positivity, Patient without anorexia nervosa and anti-HIF1a autoantibody positivity, Patient without anorexia nervosa and no anti-HIF1a autoantibody positivity |
| blood sampling after 3-4 monthsIn the event of AAHIF positivity, a second sample will be taken between 12 and 16 weeks later to verify the persistence of autoantibodies: Visit 2. | Other | Patient with anorexia nervosa and anti-HIF1a autoantibody positivity, Patient without anorexia nervosa and anti-HIF1a autoantibody positivity |
Primary outcome
Determination of anti-HIF1a autoantibodies (AAHIF) in comparison with the presence of hepatic cytolysis in patients with anorexia nervosa and undernutrition
Time frame: From enrollment to the end of study at 36 months
Comparison of the prevalence of anti-HIF1a autoantibodies (AAHIF) in patients with AM according to the presence or absence of hepatic cytolysis.
5 secondary outcomes
Rate of AAHIF in a population of healthy subjects
Time frame: From enrollment to the end of the study at 36 months
Rate of AAHIF in patients without anorexia nervosa and with hepatic cytolysis.
Time frame: From enrollment to the end of the study at 36 months
Rate of AAHIF in patients with anorexia nervosa and suffering from malnutrition
Time frame: From enrollment to the end of the study at 36 months
Rate of AAHIF according to clinico-biological criteria for AOS identified in routine care
Time frame: From enrollment to the end of the study at 36 months
Pathogenic potential in vitro of AAHIF in hepatic cytolysis
Time frame: From enrollment to the end of the study at 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling and blood sampling after 3-4 months in people with Hepatic Cytolysis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Bardin, Pr (0491435817 ext. 33, Nathalie.BARDIN@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of anti-HIF1a autoantibodies (AAHIF) in comparison with the presence of hepatic cytolysis in patients with anorexia nervosa and undernutrition (time frame: From enrollment to the end of study at 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.