NCT06262165

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 16, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

January 29, 2024

Last Update Submit

April 14, 2026

Conditions

Anorexia Nervosa

Keywords

BiomarkersLiver fibrosisLiver steatosisAnorexia nervosaEnteral refeeding

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Patients with Anorexia NervosaOTHER

Patients with Anorexia Nervosa hospitalized for malnutrition

Eligibility Criteria

Age15 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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 Nantes University Hospital.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Anorexia NervosaLiver CirrhosisFatty Liver

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 15, 2024

Study Start

February 16, 2024

Primary Completion

June 27, 2025

Study Completion

June 27, 2025

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

FR(1)