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Clinical Trials/NCT06262165
NCT06262165CompletedNot Applicable

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

Nantes University Hospital1 site in 1 country19 target enrollmentStarted: February 16, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
1
Primary Endpoint
Identification of new blood biomarkers and hepatic cytolysis
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
15 Years to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Identification of new blood biomarkers and hepatic cytolysis

Time Frame: Two years

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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