Sphingolipidomic Profile in Anorexia Nervosa
SFINGOANNER
Evaluation of the Sphingolipidomic Profile in Women Suffering From Anorexia Nervosa: Relationship With Clinical-endocrine and Psychiatric Parameters
1 other identifier
observational
60
1 country
1
Brief Summary
: The objective of this research project will be to determine the sphingolipidomic profile in a group of women (\> 18 years) affected by Anorexia Nervosa (AN), phenotypically characterized (restricting \[AN-R\] vs binge-eating purging \[AN-BP\]). Specific questionnaires will be administered for the definition of the severity of the eating disorder and depressive state (suicidality), to which will be added the evaluation of gonadal function (i.e., plasma levels of estradiol/progesterone and use of oral contraceptives). Based on the specific lipidomic profile, which the present research project hopes to characterize, it will be possible to appropriately modify the diet of rehabilitation programs and, in the future, improve the effectiveness of the treatment itself, especially in the long term.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2024
CompletedFirst Submitted
Initial submission to the registry
January 24, 2025
CompletedFirst Posted
Study publicly available on registry
January 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
March 30, 2026
March 1, 2026
2 years
January 24, 2025
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ceramides
Plasma level of ceramide
Baseline
Dihydroceramides
Plasma level of dihydroceramides
Baseline
Study Arms (2)
Anorexia Nervosa
Adult female Anorexia Nervosa patients, hospitalized at the Division of Eating and Nutrition Disorders (END), Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy
Normal weight
Adult normal-weight women with a Body Mass Index between 18.5 and 24.9 kg/m2, recruited from research and hospital staff
Interventions
The plasma/serum levels of the following sphingolipids will be measured: ceramides and dihydroceramides from C16 to C24, including 2 unsaturated ones (C18:1 and C24:1), sphingomyelins (those from C16 to C24 and the one C24:1), sphingosine, sphinganine, sphingosine-1-phosphate and sphinganine-1-phosphate.
Eligibility Criteria
30 female adults with Anorexia nervosa, according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), hospitalized at the Division of Eating and Nutrition Disorders (END), San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy. Half will have the AN-R subtype and the other AN-BP. 30 normal weight adult women recruited from research and hospital staff, with Body Mass Index between 18.5 and 24.9 kg/m2
You may qualify if:
- Female sex
- Age: 18 years or older
- Diagnosis of Anorexia Nervosa in the acute phase
- Hospitalized at the Division of Eating and Nutrition Disorders (END), San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy
You may not qualify if:
- Absence of signed Informed Consent
- Control group:
- Female sex
- Age: 18 years or older
- BMI between 18.5 and 24.9 kg/m2
- Absence of signed Informed Consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Auxologico Italiano IRCCS, Site Piancavallo
Oggebbio, Verbania, 28824, Italy
Biospecimen
Whole blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2025
First Posted
January 30, 2025
Study Start
June 19, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03