AP Metabolism Transcriptomics

IRCCS Eugenio Medea

Status

Enrolling

Conditions

Irritability

Neurodevelopmental Disorders

Treatments

Diagnostic Test: Transcriptomic investigation

Study type

Observational

Funder types

Other

Identifiers

NCT06814314

9/24 (ex 995)

Details and patient eligibility

About

It is known from the literature that treatment with antipsychotic drugs (AP) induces, even before changes in blood chemistry parameters, changes in gene transcription that are evident at the level of peripheral blood mononuclear cells.

In this pilot study we intend to evaluate the transcriptomic profile of children and adolescents who are undergoing treatment with antipsychotics and show metabolic disorders, in order to compare it to the profile of similar patients who do not use antipsychotics, but show metabolic disorders, or who use antipsychotics, but do not show metabolic disorders.

The hypothesis is that a different transcriptomic profile can be identified between the three populations under study, such as to allow to hypothesize that a series of transcripts can be used as early biomarkers of whether treatment with antipsychotics can induce metabolic disorders in the individual patient or not. This information could be used to improve the management of antipsychotic therapies in the direction of personalized medicine, reducing metabolic risks.

Enrollment

100 estimated patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age 5-17 years;
group 1: antipsychotic users with metabolic disorders;
group 2: antipsychotic users without metabolic disorders;
group 3: non-antipsychotic users with metabolic disorders. The definition of antipsychotic use includes daily use for at least 3 months prior to enrollment.

The definition of metabolic disorders includes: BMI-Z for age, sex and height > +1 Waist circumference > 90th percentile for age, sex and height Diastolic or systolic blood pressure > 90th percentile for age, sex and height Fasting blood glucose > 99 mg/dl Fasting triglycerides > 149 mg/dl Fasting cholesterol < 41 mg/dl.

Patients with metabolic disorders are defined as those who meet at least one of the above criteria.

Patients without metabolic disorders are defined as those who do not present any of the above criteria.

Exclusion criteria

presence of diagnosed genetic conditions known to alter energy metabolism and/or nutrition;
presence of diagnosed eating disorders;
habitual use of supplements known to alter energy metabolism and/or nutrition;
concomitant use of drugs known to alter energy metabolism and/or nutrition.