NCT06800898

Brief Summary

The objectives of this study will be to determine the methylation of the promoter of the Orexin A (OX-A) and B (OX-B) genes in young women (\> 18 years) with Anorexia Nervosa (AN), compared with a control group; and to evaluate the relationship of promoter methylation of the genes for OX-A and OX-B with the severity of the eating disorder, psychiatric comorbidities (in particular, depression), and sleep quality.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jun 2024Jun 2026

Study Start

First participant enrolled

June 19, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 24, 2025

Last Update Submit

March 25, 2026

Conditions

Anorexia Nervosa

Keywords

OrexinsMethylationEpigeneticsPsychiatric comorbiditiesEating disorderQuality of sleep

Outcome Measures

Primary Outcomes (2)

  • Orexin A promoter methylation

    Percentage of Orexin A promoter methylation

    Baseline

  • Orexin B promoter methylation

    Percentage of Orexin B promoter methylation

    Baseline

Study Arms (2)

Anorexia Nervosa

Young women with Anorexia Nervosa, hospitalized at the Division of Eating and Nutrition Disorders, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy,

Other: Blood samples and Questionnaires

Normal weight

Young women of comparable age with Body Mass Index between 18.5 and 24.9 kg/m2

Other: Blood samples and Questionnaires

Interventions

Blood samples and QuestionnairesOTHER

Blood samples for methylation of the promoter of the OX-A and OX-B genes and questionnaires: Eating Disorder Examination Q Eating Disorder Inventory 3 Major Depression Inventory Symptom Checklist-revised ESS - Epworth Sleepiness Scale Pittsburgh Sleep Quality Index Horne \& Ostberg questionnaire

Anorexia NervosaNormal weight

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 young women (\> 18 years old), hospitalized at the Division of Eating and Nutrition Disorders, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), for each of whom a diagnosis of AN will be formulated based on the DSM-criteria 5 (Diagnostic and Statistical Manual of Mental Disorders 5; American Psychiatric Association, 2013). For each patient, a woman of comparable age, with a BMI between 18.5 and 24.9 kg/m2, is enrolled in the control group.

You may qualify if:

  • Female sex
  • Age 18 years and older
  • Anorexia Nervosa
  • Hospitalized at the Division of Eating and Nutrition Disorders, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy

You may not qualify if:

  • Absence of signed informed consent
  • Control group:
  • Female sex
  • Age 18 years and older
  • Body Mass Index between 18.5 and 24.9 kg/m2
  • Absence of signed informed consent
  • Presence of any physical and mental pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample; with pyrosequencing, the methylation of the promoter of the OX-A and OX-B genes is evaluated using DNA extracted from peripheral nucleated cells.

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating DisordersSleep Initiation and Maintenance Disorders

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Alessandro Sartorio, MD

CONTACT

+390261911sartorio@auxologico.it

Luca Grappiolo, Dr.

CONTACT

+390261911luca.grappiolo@auxologico.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

June 19, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

IT(1)