Orexin Gene in Anorexia Nervosa

ConditionAnorexia Nervosa

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorIstituto Auxologico Italiano

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female sex

Age 18 years and older

Anorexia Nervosa

Hospitalized at the Division of Eating and Nutrition Disorders, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy

Disqualifiers

Absence of signed informed consent

Female sex

Age 18 years and older

Body Mass Index between 18.5 and 24.9 kg/m2

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Blood samples and Questionnaires
Other intervention
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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Anorexia Nervosa1 intervention

Group B: Normal weight1 intervention

Trial outcomes

Primary outcomes

Orexin A promoter methylation

Percentage of Orexin A promoter methylation

Time frame

Baseline

Orexin B promoter methylation

Percentage of Orexin B promoter methylation

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Auxologico Italiano

Lead sponsor

Source ClinicalTrials.gov

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