Sphingolipidomic Profile in Anorexia Nervosa

NCT ID: NCT06800937

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

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-19

Study Completion Date

2026-06-30

Brief Summary

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: 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.

Detailed Description

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Conditions

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Anorexia Nervosa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Anorexia Nervosa

Adult female Anorexia Nervosa patients, hospitalized at the Division of Eating and Nutrition Disorders (END), Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy

Determination of sphingolipidomic profile

Intervention Type OTHER

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.

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

Determination of sphingolipidomic profile

Intervention Type OTHER

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.

Interventions

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Determination of sphingolipidomic profile

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Absence of signed Informed Consent

Control group:


* Absence of signed Informed Consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Sartorio, MD

Role: CONTACT

+390261911 ext. 2426

Luca Grappiolo, Dr.

Role: CONTACT

+390261911

Facility Contacts

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Alessandro Sartorio

Role: primary

+39-02619111 ext. 2426

Other Identifiers

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01C417

Identifier Type: -

Identifier Source: org_study_id

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