Evaluation of Liver Damage in Patients With Anorexia Nerv... | NCT06262165

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

NCT06262165

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Apr 17, 2026Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Anorexia Nervosa

Interventions

Patients with Anorexia Nervosa

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2024Actual

Primary Completion Date

Jun 27, 2025Actual

Completion Date

Jun 27, 2025Actual

First Submitted Date

Jan 29, 2024

First Submission Date that Met QC Criteria

Feb 8, 2024

First Posted Date

Feb 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2026

Last Update Posted Date

Apr 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients with Anorexia Nervosa	Other	Patients with Anorexia Nervosa hospitalized for malnutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes	Loire-Atlantique	44093	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa
D008103	Liver Cirrhosis
D005234	Fatty Liver

Ancestor Terms

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided