[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564076":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":37,"responsibleParty":60,"collaborators":64,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":23,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":23,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Copenhagen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment in the Meta Care Clinic","ACTIVE_COMPARATOR","The patients who after randomization are allocated to the treatment arm will receive 12 months of treatment in a pragmatic metabolic clinic. Patients will receive measurements\u002Fmonitoring at least 3 times during the study period: Upon enrolment, after 6 months and after 12 months.",[13],"Other: Treatment in the Meta Care Clinic",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard care with general practitioner and\u002For outpatient clinics","The patients who after randomization are allocated for standard care will continue with their current psychiatric out-patient clinic and\u002For contact with their general practitioner. Patients will receive measurements\u002Fmonitoring upon enrolment and after 12 months.",[18],"Other: Standard care with general practitioner and\u002For outpatient clinics",[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"* Consultations by medical doctors with specific metabolic training from the metabolic clinic located at Centre for Addiction and Mental Health in Toronto, Canada, and an exercise physiologist.\n* Evaluation of their psychopharmacotherapy with consultation and detailed recommendations to the patients' treating psychiatrist and\u002For general practitioner regarding dosage reductions or switching of psychotropics if this is clinically feasible to reduce the metabolic burden.\n* Lifestyle interventions\n* Pharmacotherapy with evidence to support use to mitigate antipsychotic-induced weight gain\n* Treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and diabetes in close collaboration with recognized specialists in endocrinology.\n* Assessment of plans at conferences with participation of the sponsor, the primary investigator as well as recognized specialists in endocrinology and psychiatry.\n* Qualitative interviews will be conducted post-intervention.",[9],null,{"type":6,"name":15,"description":25,"armGroupLabels":26,"otherNames":23},"Following measurements after 12 months, patients will receive individualized lifestyle recommendations from an exercise physiologist and a MD will offer to send recommendations regarding the following potential post-trial interventions to the patients' general practitioner and\u002For outpatient clinic prepared in close collaboration with recognized specialists in psychiatry and endocrinology:\n\n* Suggestions regarding relevant psychotropic medication adjustments or switches if this is found relevant and clinically feasible to reduce the metabolic burden.\n* Suggestions regarding potential add-on of weight reducing pharmacotherapy.\n* Suggestions regarding pharmacological treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and type 2 diabetes.",[15],[28],{"name":29,"affiliation":30,"role":31},"Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,","Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup | University of Copenhagen","STUDY_CHAIR",[33],{"name":29,"role":34,"phone":35,"phoneExt":23,"email":36},"CONTACT","+4538640840","bjoern.ebdrup@regionh.dk",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup","RECRUITING","Glostrup Municipality","Capital Region","2600","Denmark","DK",{"type":47,"coordinates":48},"Point",[49,50],12.40377,55.6666,{"lat":50,"lon":49},[53,56],{"name":54,"role":34,"phone":35,"phoneExt":23,"email":55},"Bjorn H Ebdrup, MD, Consultant,PhD, Professor,","bebdrup@cnsr.dk",{"name":57,"role":34,"phone":58,"phoneExt":23,"email":59},"Grimur H Mohr, MD","+45 38 64 08 40","grimur.hoegnason.mohr@regionh.dk",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Bjorn H. Ebdrup","MD, consultant, PhD and clinical professor in psychiatry Bjørn Hylsebeck Ebdrup",[65,67,69],{"name":66,"class":6},"Glostrup University Hospital, Copenhagen",{"name":68,"class":6},"University of Toronto",{"name":70,"class":6},"Herlev and Gentofte Hospital","100564076","effectiveness-of-a-pragmatic-metabolic-care-clinic-for-patients-with-severe-mental-illness---the-meta-care-clinic-100564076",false,"NCT06624462","Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic","Inclusion Criteria:\n\n* Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)\n* Medical treatment with antipsychotics\n* Age 18-45 years\n* Legally competent\n* Able to give informed consent\n\nand either:\n\n\\- Body mass index (BMI) ≥30 kg\u002Fm2.\n\nOr\n\n* BMI ≥27 kg\u002Fm2 and at least one of the following:\n* Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office \u002F 24-hour, non-invasive ambulatory blood pressure ≥140\u002F90 mmHg within the previous 6 months\n* Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol\u002Fl), elevated triglycerides (≥1.7 mmol\u002Fl) or low high-density lipoprotein cholesterol (≥1.2 mmol\u002Fl in women and ≥1.0 mmol\u002Fl in men) within the previous 6 months\n* Sleep apnoea (ICD-10 DG473).\n* Prediabetes or diabetes defined as HbA1c ≥42 mmol\u002Fmol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months.\n\nOr\n\n\\- a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy.\n\nExclusion Criteria:\n\n* Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team.\n* Unstable psychiatric disorder as judged by the research team.\n* Severe current drug or alcohol misuse as judged by the research team.\n* Acute suicidal risk.","ALL","18 Years","45 Years",{"count":81,"type":82},84,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness",[88,89,90,91,92],"Severe Mental Disorder","Metabolic Complication","Side-Effect;Medication","Schizophrenia Spectrum and Other Psychotic Disorders","Bipolar Disorder",[94,95,96,97,98,99],"Severe mental illness","Overweight and obesity","Antipsychotic medication","Dysmetabolism","Schizophrenia Spectrum Disorders","Bipolar disorder","2026-01-06",{"date":102,"type":103},"2026-01-08","ACTUAL",{"date":105,"type":103},"2023-10-10",{"date":107,"type":82},"2026-12-31",{"name":62,"class":6},1]