This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)
Medical treatment with antipsychotics
Age 18-45 years
Legally competent
Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team.
Unstable psychiatric disorder as judged by the research team.
Severe current drug or alcohol misuse as judged by the research team.
Acute suicidal risk.
Parallel
Treatment in the Meta Care Clinic
Other intervention* 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. * Evaluation of their psychopharmacotherapy with consultation and detailed recommendations to the patients' treating psychiatrist and/or general practitioner regarding dosage reductions or switching of psychotropics if this is clinically feasible to reduce the metabolic burden. * Lifestyle interventions * Pharmacotherapy with evidence to support use to mitigate antipsychotic-induced weight gain * Treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and diabetes in close collaboration with recognized specialists in endocrinology. * Assessment of plans at conferences with participation of the sponsor, the primary investigator as well as recognized specialists in endocrinology and psychiatry. * Qualitative interviews will be conducted post-intervention.
Standard care with general practitioner and/or outpatient clinics
Other interventionFollowing 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/or outpatient clinic prepared in close collaboration with recognized specialists in psychiatry and endocrinology: * Suggestions regarding relevant psychotropic medication adjustments or switches if this is found relevant and clinically feasible to reduce the metabolic burden. * Suggestions regarding potential add-on of weight reducing pharmacotherapy. * Suggestions regarding pharmacological treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and type 2 diabetes.
Proportion of patients achieving a weight loss of ≥5% of initial body weight.
Proportion of patients in the intervention group achieving a weight loss of ≥5% of initial body weight vs the standard care group at 12 months.
The metabolic composite score
The metabolic composite score consisting of minimally 0 points and maximally five points (one point per composite; elevated waist circumference, elevated triglycerides, blood pressure, fasting plasma glucose, and reduced high-density lipoprotein), according to the definition and cut-off values of metabolic syndrome by the International Diabetes Federation. A higher score means worse outcomes. Effect measurements: differences in percentage achieving reduction of ≥1 points between groups at 12 months.
Cardiovascular risk factors
Cardiovascular risk factors as defined below.
Proportion of patients achieving a weight loss of ≥10% of initial body weight.
Proportion of patients in the intervention group achieving a weight loss of ≥10% of initial body weight vs the standard care group at 12 months.
Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol
Proportion of patients in the intervention group achieving a ≥50% reduction of initial low-density lipoprotein cholesterol vs the standard care group at 12 months.
Cardiorespiratory fitness
Cardiorespiratory fitness assessed by the submaximal Ekblom-Bak test on a mechanically braked cycle ergometer. Effect measurements: differences in mean changes between groups at 12 months.
Body composition: Total body fat percentage
Total body fat percentage measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months.
Body composition: Visceral adipose tissue
Visceral adipose tissue measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months.
Body composition: Skeletal muscle mass.
Skeletal muscle mass measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months.
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Bjorn H. Ebdrup
Lead sponsor
University of Copenhagen
Sponsor institution
Glostrup University Hospital, Copenhagen
Collaborator
University of Toronto
Collaborator
Herlev and Gentofte Hospital
Collaborator
