- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262165
Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis (BILAN)
April 14, 2026 updated by: Nantes University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study of the association between blood biomarkers and the presence of hepatic cytolysis, defined by AST and/or ALT above normal.
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Loire-Atlantique
-
Nantes, Loire-Atlantique, France, 44093
- Nantes University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Consecutive inclusion of patients hospitalized in the endocrinology department for anorexia nervosa with malnutrition criteria.
Description
Inclusion Criteria :
- 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.
Exclusion Criteria :
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 16, 2024
Primary Completion (Actual)
June 27, 2025
Study Completion (Actual)
June 27, 2025
Study Registration Dates
First Submitted
January 29, 2024
First Submitted That Met QC Criteria
February 8, 2024
First Posted (Actual)
February 15, 2024
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 14, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC23_0497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anorexia Nervosa
-
Baylor College of MedicineEnrolling by invitationAnorexia Nervosa | Atypical Anorexia NervosaUnited States
-
Rosemary Claire RodenChildren's Miracle NetworkTerminatedBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
University of California, San DiegoActive, not recruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa in RemissionUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3RecruitingAnorexia Nervosa | Anorexia Nervosa in Remission | Anorexia Nervosa Restricting TypeSpain
-
Duke UniversityCompletedAdolescent Anorexia Nervosa | Subthreshold Anorexia NervosaUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
-
Istituto Auxologico ItalianoCatholic University of the Sacred Heart; University of Turin, Italy; Open University and other collaboratorsRecruitingAnorexia Nervosa/BulimiaItaly
-
Maimónides Biomedical Research Institute of CórdobaHospital Universitario Reina Sofia de CordobaNot yet recruitingAnorexia Nervosa Restricting Type | Anorexia Nervosa (DSM-IV Revised Criteria)Spain
-
University Hospital, MontpellierCompleted
Clinical Trials on Patients with Anorexia Nervosa
-
Charite University, Berlin, GermanyUniversity of SydneyCompleted
-
University of KansasChildren's Mercy Hospital Kansas City; Purdue UniversityRecruiting
-
Istituto per la Ricerca e l'Innovazione BiomedicaCatholic University of the Sacred Heart; Madre Teresa s.r.l; Medilink s.r.l.; SB...RecruitingAnorexia Nervosa | Bulimia Nervosa | Eating DisordersItaly
-
Göteborg UniversityNot yet recruitingAnorexia Nervosa | Autism Spectrum Disorder
-
Baylor College of MedicineEnrolling by invitationAnorexia Nervosa | Atypical Anorexia NervosaUnited States
-
University College, LondonNorth East London Foundation TrustNot yet recruiting
-
Helsinki University Central HospitalCompleted
-
Massachusetts General HospitalEnrolling by invitationAnorexia NervosaUnited States
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)CompletedEating DisordersUnited States
-
Poitiers University HospitalCompleted