- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05861375
Liver Biomarkers in Anorexia Nervosa (LIBAN)
April 14, 2026 updated by: Nantes University Hospital
Assessment of Liver Damage Using the Fibroscan in Patients With Anorexia Nervosa
The main goal of the Liver Biomarkers in Anorexia Nervosa (LIBAN) study is to determine the prevalence of liver fibrosis in patient with Anorexia Nervosa.
Study Overview
Detailed Description
Prevalence of hepatic fibrosis will be non-invasively investigated, in the Anorexia Nervosa inpatient population, using the Fibroscan ®.
Furthermore, liver blood markers will be assessed.
Study Type
Observational
Enrollment (Actual)
43
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
-
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Loire-Atlantique
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Nantes, Loire-Atlantique, France, 44093
- Nantes University Hospital
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-
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
Non-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 the endocrinology, diabetology and nutrition department of the Nantes University Hospital.
Exclusion Criteria :
- Chronic active viral hepatitis
- Hemochromatosis
- Other genetic, autoimmune, toxic or drug-induced hepatitis
- 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)
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non applicable (NA)
Patients with Anorexia Nervosa hospitalized for malnutrition
|
Fibroscan is a non-invasive device that allows liver exploration painlessly, quickly (a few minutes) and with immediate results.
A probe placed on the skin generates an elastic wave completely painlessly and the device measures its speed of propagation in the liver.
Liver stiffness is calculated from this speed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liver fibrosis prevalence in patients with Anorexia nervosa
Time Frame: Day one
|
Liver stiffness will be assessed using Fibroscan (kPA) within the 24 hours following admission to the endocrinology, diabetology and nutrition department.
|
Day one
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarra SMATI-GRANGEON, PH, Nantes University Hospital
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)
June 23, 2023
Primary Completion (Actual)
June 27, 2025
Study Completion (Actual)
June 27, 2025
Study Registration Dates
First Submitted
February 7, 2023
First Submitted That Met QC Criteria
May 12, 2023
First Posted (Actual)
May 16, 2023
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_0049
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.