Orexin Gene in Anorexia Nervosa

NCT ID: NCT06800898

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-19

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anorexia Nervosa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anorexia Nervosa

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

Blood samples and Questionnaires

Intervention Type 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

Normal weight

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

Blood samples and Questionnaires

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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

Control group:


* Absence of signed informed consent
* Presence of any physical and mental pathology
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alessandro Sartorio, MD

Role: CONTACT

+390261911 ext. 2426

Luca Grappiolo, Dr.

Role: CONTACT

+390261911 ext. 2894

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alessandro Sartorio, MD

Role: primary

+39-02619111 ext. 2426

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01C414

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anorexia Nervosa and Brain in Adolescence
NCT06380257 NOT_YET_RECRUITING