Liver Biomarkers in Anorexia Nervosa

NCT05861375 | Completed

• 1 other identifier: RC23_0049
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa

Keywords

Liver Fibrosis; Liver Steatosis; Enteral Refeeding; Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Non applicable (NA)

Patients with Anorexia Nervosa hospitalized for malnutrition

Diagnostic Test: Fibroscan

Interventions

Fibroscan DIAGNOSTIC_TEST

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.

Non applicable (NA)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive inclusion of patients hospitalized in the endocrinology department for anorexia nervosa with malnutrition criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

These are blood samples that may be used for further research.

MeSH Terms

Conditions

Anorexia Nervosa; Liver Cirrhosis; Fatty Liver

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarra SMATI-GRANGEON, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: May 16, 2023
• Study Start: June 23, 2023
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

FR (1)