Sphingolipidomic Profile in Anorexia Nervosa

ConditionAnorexia Nervosa

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorIstituto Auxologico Italiano

About this trial

: 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Absence of signed Informed Consent

Female sex

Age: 18 years or older

BMI between 18.5 and 24.9 kg/m2

Trial 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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Determination of sphingolipidomic profile
Other intervention
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Anorexia Nervosa1 intervention

Group B: Normal weight1 intervention

Trial outcomes

Primary outcomes

Ceramides

Plasma level of ceramide

Time frame

Baseline

Dihydroceramides

Plasma level of dihydroceramides

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Auxologico Italiano

Lead sponsor

Source ClinicalTrials.gov

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