Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-04-30
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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AP+ / MetS+
Persons using antipsychotic drugs and meeting diagnostic criteria for the metabolic syndrome
Transcriptomic investigation
Transcriptomic investigation followed by ontology classification
AP+ / MetS-
Persons using antipsychotic drugs not meeting diagnostic criteria for the metabolic syndrome
Transcriptomic investigation
Transcriptomic investigation followed by ontology classification
AP- / MetS+
Persons meeting diagnostic criteria for the metabolic syndrome not using antipsychotic drugs
Transcriptomic investigation
Transcriptomic investigation followed by ontology classification
Interventions
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Transcriptomic investigation
Transcriptomic investigation followed by ontology classification
Eligibility Criteria
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Inclusion Criteria
* 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 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.
5 Years
17 Years
ALL
No
Sponsors
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IRCCS Eugenio Medea
OTHER
Responsible Party
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Locations
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IRCCS Eugenio Medea
Bosisio Parini, LC, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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9/24 (ex 995)
Identifier Type: -
Identifier Source: org_study_id
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