Anorexia NervosaBILANNCT06262165
Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis
An observational study of Anorexia Nervosa, run by Nantes University Hospital at 1 site in France.
Trial summary
The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis. Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Patients with Anorexia Nervosa
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2024to 27 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive inclusion of patients hospitalized in the endocrinology department for anorexia nervosa with malnutrition criteria.
Who may be able to join
- Patient over 15 years old
- Diagnosis of Restricted Eating Disorders including Anorexia Nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Admission to Nantes University Hospital.
Who cannot join
- Chronic active viral hepatitis
- Hemochromatosis
- Other genetic, autoimmune.
- Treatment with a drug known to induce fatty liver disease (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals) unless the dose has been stable for ≥ 3 months
- Excessive alcohol consumption (≥ 30 grams per day in men, ≥ 20 grams per day in women)
- Pregnant, parturient or breast-feeding women, persons deprived of liberty, adults under legal protection or unable to express their consent, persons not affiliated or not beneficiaries of a social security scheme, persons under guardianship or curators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BILAN: Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood BIomarker ANaLysis
The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis.
Read the detailed description
Study of the association between blood biomarkers and the presence of hepatic cytolysis, defined by AST and/or ALT above normal.
- Conditions
- Anorexia Nervosa
- Being tested
- Patients with Anorexia Nervosa
- Keywords
- Biomarkers, Liver fibrosis, Liver steatosis, Anorexia nervosa, Enteral refeeding
- Medical subject headings
- Anorexia Nervosa, Liver Cirrhosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with Anorexia NervosaOther
Patients with Anorexia Nervosa hospitalized for malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of new blood biomarkers and hepatic cytolysis
Identify changes in concentration of new blood biomarkers in patients suffering from hepatic cytolysis, defined by aspartate transaminases (AST) and/or alanine transaminases (ALT) above normal values, compared to those with normal enzyme levels.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start16 Feb 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262165
- Sponsor's protocol ID
- RC23_0497
- Acronym
- BILAN
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BILAN: Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood BIomarker ANaLysis
- ClinicalTrials.gov ID
- NCT06262165
- Acronym / sponsor ID
- BILAN / RC23_0497
- Conditions
- Anorexia Nervosa
- Keywords
- Biomarkers, Liver fibrosis, Liver steatosis, Anorexia nervosa, Enteral refeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 15 Feb 2024 (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.
The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis.
Detailed description
Study of the association between blood biomarkers and the presence of hepatic cytolysis, defined by AST and/or ALT above normal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive inclusion of patients hospitalized in the endocrinology department for anorexia nervosa with malnutrition criteria.
Key inclusion criteria (3 listed)
- Patient over 15 years old
- Diagnosis of Restricted Eating Disorders including Anorexia Nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Admission to Nantes University Hospital.
Key exclusion criteria (6 listed)
- Chronic active viral hepatitis
- Hemochromatosis
- Other genetic, autoimmune.
- Treatment with a drug known to induce fatty liver disease (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals) unless the dose has been stable for ≥ 3 months
- Excessive alcohol consumption (≥ 30 grams per day in men, ≥ 20 grams per day in 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 |
|---|---|---|
| Patients with Anorexia NervosaPatients with Anorexia Nervosa hospitalized for malnutrition | Other | – |
Primary outcome
Identification of new blood biomarkers and hepatic cytolysis
Time frame: Two years
Identify changes in concentration of new blood biomarkers in patients suffering from hepatic cytolysis, defined by aspartate transaminases (AST) and/or alanine transaminases (ALT) above normal values, compared to those with normal enzyme levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Nantes University Hospital 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 17 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of new blood biomarkers and hepatic cytolysis (time frame: Two years). 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 17 Apr 2026.