Liver Biomarkers in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— LIBAN  

Official title:

Assessment of Liver Damage Using the Fibroscan in Patients With Anorexia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861375
• Other study ID #: RC23_0049
• Status: Recruiting
• Start date: June 23, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: Sarra SMATI-GRANGEON, PH
• Phone: 33 2.53.48.27.01
• Email: sarra.grangeon[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Diagnostic Test:
• Fibroscan
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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fibrosis prevalence in patients with Anorexia nervosa	Liver stiffness will be assessed using Fibroscan (kPA) within the 24 hours following admission to the endocrinology, diabetology and nutrition department.	Day one