Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

⁃ Or

• 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.

⁃ Or

⁃ \- 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.

Locations
Other Locations
Denmark
Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup
RECRUITING
Glostrup Municipality
Contact Information
Primary
Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,
bjoern.ebdrup@regionh.dk
+4538640840
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Treatment in the Meta Care Clinic
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/monitoring at least 3 times during the study period: Upon enrolment, after 6 months and after 12 months.
Active_comparator: Standard care with general practitioner and/or outpatient clinics
The patients who after randomization are allocated for standard care will continue with their current psychiatric out-patient clinic and/or contact with their general practitioner. Patients will receive measurements/monitoring upon enrolment and after 12 months.
Sponsors
Collaborators: University of Toronto, Herlev and Gentofte Hospital, Mental Health Centre Glostrup
Leads: Bjorn H. Ebdrup

This content was sourced from clinicaltrials.gov