AP Metabolism Transcriptomics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-17
SponsorIRCCS Eugenio Medea
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Persons with metabolic syndrome and/or users of antipsychotic drugs
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Transcriptomic investigation
Diagnostic testTranscriptomic investigation followed by ontology classification
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: AP+ / MetS+1 intervention
Group B: AP+ / MetS-1 intervention
Group C: AP- / MetS+1 intervention
Trial outcomes
Primary outcomes
1
BMI-Z
Body mass index, normalized by age and sex. Values below -1 indicate underweight, values below 1 indicate overweight.
Time frame
Once, at recruitmentSponsors and contacts
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Source ClinicalTrials.gov