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NCT Number: NCT06800937

Sphingolipidomic Profile in Anorexia Nervosa

: 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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location status: Recruiting

Location contact

Alessandro Sartorio

CONTACT

[email protected]

+39-02619111 ext. 2426

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients with Anorexia Nervosa:

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

Exclusion criteria

  • Absence of signed Informed Consent

Control group:

Inclusion criteria

  • Female sex
  • Age: 18 years or older
  • BMI between 18.5 and 24.9 kg/m2

Exclusion criteria

  • Absence of signed Informed Consent

Treatment and study plan

Determination of sphingolipidomic profile

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.

Primary outcomes

  1. Ceramides

    Time frame: Baseline

    Plasma level of ceramide

  2. Dihydroceramides

    Time frame: Baseline

    Plasma level of dihydroceramides

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Sartorio, MD

CONTACT

[email protected]

+390261911 ext. 2426

Luca Grappiolo, Dr.

CONTACT

[email protected]

+390261911

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Evaluation of the Sphingolipidomic Profile in Women Suffering From Anorexia Nervosa: Relationship With Clinical-endocrine and Psychiatric Parameters

Acronym: SFINGOANNER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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