AP Metabolism Transcriptomics
Pilot Study of Transcriptomic Alterations Associated with Antipsychotic-induced Metabolic Disorders in Children and Adolescents
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marco Pozzi, PhD
- Phone Number: +39 031877919
- Email: marco.pozzi@lanostrafamiglia.it
Study Locations
-
-
LC
-
Bosisio Parini, LC, Italy, 23842
- Recruiting
- IRCCS Eugenio Medea
-
Contact:
- Marco Pozzi, PhD
- Phone Number: +39 031877919
- Email: marco.pozzi@lanostrafamiglia.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
AP+ / MetS+
Persons using antipsychotic drugs and meeting diagnostic criteria for the metabolic syndrome
|
Transcriptomic investigation followed by ontology classification
|
|
AP+ / MetS-
Persons using antipsychotic drugs not meeting diagnostic criteria for the metabolic syndrome
|
Transcriptomic investigation followed by ontology classification
|
|
AP- / MetS+
Persons meeting diagnostic criteria for the metabolic syndrome not using antipsychotic drugs
|
Transcriptomic investigation followed by ontology classification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI-Z
Time Frame: Once, at recruitment
|
Body mass index, normalized by age and sex.
Values below -1 indicate underweight, values below 1 indicate overweight.
|
Once, at recruitment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9/24 (ex 995)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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