Liver Biomarkers in Anorexia Nervosa

NCT ID: NCT05861375

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-23

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anorexia Nervosa

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Non applicable (NA)

Patients with Anorexia Nervosa hospitalized for malnutrition

Fibroscan

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarra SMATI-GRANGEON, PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, Loire-Atlantique, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sarra SMATI-GRANGEON, PH

Role: CONTACT

33 2.53.48.27.01

An THYS, PH

Role: CONTACT

33 2.53.48.27.06

Other Identifiers

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RC23_0049

Identifier Type: -

Identifier Source: org_study_id

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