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Recruiting NCT06800937

Sphingolipidomic Profile in Anorexia Nervosa

Observational Anorexia Nervosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Determination of sphingolipidomic profile.
Who it may be relevant to
Registry conditions: Anorexia Nervosa. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

: 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.

Interventions

  • Other 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.

Primary outcome measures

  • Ceramides [Time frame: Baseline]
  • Dihydroceramides [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Istituto Auxologico Italiano IRCCS, Site Piancavallo — Oggebbio

Identifiers

NCT: NCT06800937 · 01C417

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗