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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05861375
Other study ID # RC23_0049
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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