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NCT06262165 Clinical Trial

Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis

Anorexia Nervosa Clinical Trial

— BILAN  

Official title:
BILAN: Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood BIomarker ANaLysis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06262165
Other study ID # RC23_0497
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 16, 2024
Est. completion date December 15, 2032

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 BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis.

Description:

Study of the association between blood biomarkers and the presence of hepatic cytolysis, defined by AST and/or ALT above normal.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 15, 2032
Est. primary completion date June 15, 2032
Accepts healthy volunteers No
Gender All
Age group 15 Years to 99 Years
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 Nantes University Hospital. Exclusion Criteria : - Chronic active viral hepatitis - Hemochromatosis - Other genetic, autoimmune. - 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) - Pregnant, parturient or breast-feeding women, persons deprived of liberty, adults under legal protection or unable to express their consent, persons not affiliated or not beneficiaries of a social security scheme, persons under guardianship or curators

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Patients with Anorexia Nervosa
Patients with Anorexia Nervosa hospitalized for malnutrition

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 Identification of new blood biomarkers and hepatic cytolysis Identify changes in concentration of new blood biomarkers in patients suffering from hepatic cytolysis, defined by aspartate transaminases (AST) and/or alanine transaminases (ALT) above normal values, compared to those with normal enzyme levels. Two years
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