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NCT Number: NCT06800898

Orexin Gene in Anorexia Nervosa

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.

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Key information

Conditions

Anorexia Nervosa Dyssomnias Feeding and Eating Disorders Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location status: Recruiting

Location contact

Alessandro Sartorio, MD

CONTACT

[email protected]

+39-02619111 ext. 2426

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood samples and Questionnaires

Other

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

Primary outcomes

  1. Orexin A promoter methylation

    Time frame: Baseline

    Percentage of Orexin A promoter methylation

  2. Orexin B promoter methylation

    Time frame: Baseline

    Percentage of Orexin B promoter methylation

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Sartorio, MD

CONTACT

[email protected]

+390261911 ext. 2426

Luca Grappiolo, Dr.

CONTACT

[email protected]

+390261911 ext. 2894

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: ORESSANNE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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