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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP+ / MetS+ | Persons using antipsychotic drugs and meeting diagnostic criteria for the metabolic syndrome |
| |
| AP+ / MetS- | Persons using antipsychotic drugs not meeting diagnostic criteria for the metabolic syndrome |
| |
| AP- / MetS+ | Persons meeting diagnostic criteria for the metabolic syndrome not using antipsychotic drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcriptomic investigation | Diagnostic Test | Transcriptomic investigation followed by ontology classification |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI-Z | Body mass index, normalized by age and sex. Values below -1 indicate underweight, values below 1 indicate overweight. | Once, at recruitment |
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Inclusion Criteria:
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:
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Persons with metabolic syndrome and/or users of antipsychotic drugs
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Pozzi, PhD | Contact | 031877919 | +39 | marco.pozzi@lanostrafamiglia.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Eugenio Medea | Recruiting | Bosisio Parini | LC | 23842 | Italy |
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| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D050171 | Dyslipidemias |
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |