Anorexia NervosaSFINGOANNERNCT06800937
Sphingolipidomic Profile in Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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]). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Determination of sphingolipidomic profile
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
- Female sex
- Age: 18 years or older
- BMI between 18.5 and 24.9 kg/m2
Who cannot join
- Absence of signed Informed Consent
- Control group:
- Absence of signed Informed Consent
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, +39-02619111 ext. 2426, sartorio@auxologico.it
About this study
Official title: Evaluation of the Sphingolipidomic Profile in Women Suffering From Anorexia Nervosa: Relationship With Clinical-endocrine and Psychiatric Parameters
: 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Determination of sphingolipidomic profile
- Keywords
- Anorexia nervosa, Sphingolipids, Females, Lipidomic profile
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of sphingolipidomic profileOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa | Adult female Anorexia Nervosa patients, hospitalized at the Division of Eating and Nutrition Disorders (END), Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy Receives: Other: Determination of sphingolipidomic profile | |
| 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 Receives: Other: Determination of sphingolipidomic profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ceramides
Plasma level of ceramide
Measured: Baseline
Dihydroceramides
Plasma level of dihydroceramides
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
- NCT06800937
- Sponsor's protocol ID
- 01C417
- Acronym
- SFINGOANNER
- 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
- Evaluation of the Sphingolipidomic Profile in Women Suffering From Anorexia Nervosa: Relationship With Clinical-endocrine and Psychiatric Parameters
- ClinicalTrials.gov ID
- NCT06800937
- Acronym / sponsor ID
- SFINGOANNER / 01C417
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Sphingolipids, Females, Lipidomic profile
- 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa | – | Other: Determination of sphingolipidomic profileAdult female Anorexia Nervosa patients, hospitalized at the Division of Eating and Nutrition Disorders (END), Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy |
| Normal weight | – | Other: Determination of sphingolipidomic profileAdult normal-weight women with a Body Mass Index between 18.5 and 24.9 kg/m2, recruited from research and hospital staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (7 listed)
- 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
- Female sex
Key exclusion criteria (3 listed)
- Absence of signed Informed Consent
- Absence of signed Informed Consent
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 |
|---|---|---|
| Determination of sphingolipidomic profileThe 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. | Other | Anorexia Nervosa, Normal weight |
Primary outcome
Ceramides
Time frame: Baseline
Plasma level of ceramide
Dihydroceramides
Time frame: Baseline
Plasma level of dihydroceramides
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 3 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?
Ceramides (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.