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Recruiting NCT06800898

Orexin Gene in Anorexia Nervosa

Observational Anorexia Nervosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood samples and Questionnaires.
Who it may be relevant to
Registry conditions: Anorexia Nervosa. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Orexin A promoter methylation [Time frame: Baseline]
  • Orexin B promoter methylation [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Istituto Auxologico Italiano IRCCS, Site Piancavallo — Oggebbio

Identifiers

NCT: NCT06800898 · 01C414

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗