Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Recruiting · NCT06624462 · Interventional (participants receive a specific treatment) · Lead sponsor: Bjorn H. Ebdrup
View the official record on ClinicalTrials.gov →Interventions studied
Standard care with general practitioner and/or outpatient clinicsTreatment in the Meta Care Clinic
What this trial is about
This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
Who can take part
Age range
18 Years to 45 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Able to give informed consent
- and either:
- \- Body mass index (BMI) ≥30 kg/m2.
- BMI ≥27 kg/m2 and at least one of the following:
- Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office / 24-hour, non-invasive ambulatory blood pressure ≥140/90 mmHg within the previous 6 months
- Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol/l), elevated triglycerides (≥1.7 mmol/l) or low high-density lipoprotein cholesterol (≥1.2 mmol/l in women and ≥1.0 mmol/l in men) within the previous 6 months
- Sleep apnoea (ICD-10 DG473).
- Prediabetes or diabetes defined as HbA1c ≥42 mmol/mol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months.
- \- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup - Glostrup Municipality, Capital Region, Denmark