Orexin Gene in Anorexia Nervosa (ORESSANNE)

March 25, 2026 updated by: Istituto Auxologico Italiano

The Methylation Level of the Orexin Gene in Anorexia Nervosa: Relationship With Eating Disorder, Depressive State, and Sleep Quality

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Verbania
      • Oggebbio, Verbania, Italy, 28824
        • Recruiting
        • Istituto Auxologico Italiano IRCCS, Site Piancavallo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Patients with Anorexia Nervosa:

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of signed informed consent

Control group:

Inclusion Criteria:

  • Female sex
  • Age 18 years and older
  • Body Mass Index between 18.5 and 24.9 kg/m2

Exclusion Criteria:

  • Absence of signed informed consent
  • Presence of any physical and mental pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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
Normal weight
Young women of comparable age with Body Mass Index between 18.5 and 24.9 kg/m2
Other: Blood samples and Questionnaires

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orexin A promoter methylation
Time Frame: Baseline
Percentage of Orexin A promoter methylation
Baseline
Orexin B promoter methylation
Time Frame: Baseline
Percentage of Orexin B promoter methylation
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01C414

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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