[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578670":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":35,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"IRCCS Eugenio Medea","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"AP+ \u002F MetS+",null,"Persons using antipsychotic drugs and meeting diagnostic criteria for the metabolic syndrome",[13],"Diagnostic Test: Transcriptomic investigation",{"label":15,"type":10,"description":16,"interventionNames":17},"AP+ \u002F MetS-","Persons using antipsychotic drugs not meeting diagnostic criteria for the metabolic syndrome",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"AP- \u002F MetS+","Persons meeting diagnostic criteria for the metabolic syndrome not using antipsychotic drugs",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Transcriptomic investigation","Transcriptomic investigation followed by ontology classification",[9,15,19],[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Marco Pozzi, PhD","CONTACT","031877919","+39","marco.pozzi@lanostrafamiglia.it",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Bosisio Parini","LC","23842","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],9.29,45.80075,{"lat":47,"lon":46},[50],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100578670","ap-metabolism-transcriptomics-100578670",false,"NCT06814314","AP Metabolism Transcriptomics","Pilot Study of Transcriptomic Alterations Associated with Antipsychotic-induced Metabolic Disorders in Children and Adolescents","Inclusion Criteria:\n\n* age 5-17 years;\n* group 1: antipsychotic users with metabolic disorders;\n* group 2: antipsychotic users without metabolic disorders;\n* group 3: non-antipsychotic users with metabolic disorders. The definition of antipsychotic use includes daily use for at least 3 months prior to enrollment.\n\nThe 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\u002Fdl Fasting triglycerides \\> 149 mg\u002Fdl Fasting cholesterol \\\u003C 41 mg\u002Fdl.\n\nPatients with metabolic disorders are defined as those who meet at least one of the above criteria.\n\nPatients without metabolic disorders are defined as those who do not present any of the above criteria.\n\nExclusion Criteria:\n\n* presence of diagnosed genetic conditions known to alter energy metabolism and\u002For nutrition;\n* presence of diagnosed eating disorders;\n* habitual use of supplements known to alter energy metabolism and\u002For nutrition;\n* concomitant use of drugs known to alter energy metabolism and\u002For nutrition.","ALL","5 Years","17 Years",{"count":64,"type":65},100,"ESTIMATED","OBSERVATIONAL","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.\n\nIn 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.\n\nThe 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.",[69,70],"Neurodevelopmental Disorders","Irritability",[72,73,74,75,76],"antipsychotic drugs","dyslipidemia","pre-diabetes","obesity","transcriptomics","2025-02-03",{"date":79,"type":80},"2025-02-07","ACTUAL",{"date":82,"type":80},"2023-04-30",{"date":84,"type":65},"2026-05",{"name":5,"class":6},1]