Anorexia NervosaORESSANNENCT06800898
Orexin Gene in Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Blood samples and Questionnaires
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Absence of signed informed consent
- Control group:
- Absence of signed informed consent
- Presence of any physical and mental pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS, Site Piancavallo
Oggebbio, Verbania, 28824
Alessandro Sartorio, MD, +39-02619111 ext. 2426, sartorio@auxologico.it
About this study
Official title: 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Blood samples and Questionnaires
- Keywords
- Orexins, Methylation, Epigenetics, Psychiatric comorbidities, Eating disorder, Quality of sleep
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa | Young women with Anorexia Nervosa, hospitalized at the Division of Eating and Nutrition Disorders, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy, Receives: Other: Blood samples and Questionnaires | |
| Normal weight | Young women of comparable age with Body Mass Index between 18.5 and 24.9 kg/m2 Receives: Other: Blood samples and Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orexin A promoter methylation
Percentage of Orexin A promoter methylation
Measured: Baseline
Orexin B promoter methylation
Percentage of Orexin B promoter methylation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start19 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800898
- Sponsor's protocol ID
- 01C414
- Acronym
- ORESSANNE
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Methylation Level of the Orexin Gene in Anorexia Nervosa: Relationship With Eating Disorder, Depressive State, and Sleep Quality
- ClinicalTrials.gov ID
- NCT06800898
- Acronym / sponsor ID
- ORESSANNE / 01C414
- Conditions
- Anorexia Nervosa
- Keywords
- Orexins, Methylation, Epigenetics, Psychiatric comorbidities, Eating disorder, Quality of sleep
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa | – | Other: Blood samples and QuestionnairesYoung women with Anorexia Nervosa, hospitalized at the Division of Eating and Nutrition Disorders, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy, |
| Normal weight | – | Other: Blood samples and QuestionnairesYoung women of comparable age with Body Mass Index between 18.5 and 24.9 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Absence of signed informed consent
- Absence of signed informed consent
- Presence of any physical and mental pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples and QuestionnairesBlood 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 | Other | Anorexia Nervosa, Normal weight |
Primary outcome
Orexin A promoter methylation
Time frame: Baseline
Percentage of Orexin A promoter methylation
Orexin B promoter methylation
Time frame: Baseline
Percentage of Orexin B promoter methylation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Sartorio, MD (+390261911 ext. 2426, sartorio@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orexin A promoter methylation (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.