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

NCT06624462 | Recruiting

• 4 other identifiers: The Meta Care ClinicH-23045618p-2023-143422096-00099B
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Complication; Side-Effect;Medication; Bipolar Disorder; Severe Mental Disorder; Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

Severe mental illness; Overweight and obesity; Antipsychotic medication; Dysmetabolism; Schizophrenia Spectrum Disorders; Bipolar disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (18)

• The metabolic composite score

  12 months

• Cardiovascular risk factors

  12 months

• Proportion of patients achieving a weight loss of ≥10% of initial body weight.

  12 months

• Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol

  12 months

• Body weight

  12 months

Other Outcomes (13)

• Cardiorespiratory fitness

  12 months

• Body composition: Total body fat percentage

  12 months

• Body composition: Visceral adipose tissue

  12 months

Study Arms (2)

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/monitoring at least 3 times during the study period: Upon enrolment, after 6 months and after 12 months.

Other: Treatment in the Meta Care Clinic

Standard care with general practitioner and/or outpatient clinics

ACTIVE COMPARATOR

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.

Other: Standard care with general practitioner and/or outpatient clinics

Interventions

Treatment in the Meta Care Clinic OTHER

* 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.

Treatment in the Meta Care Clinic

Standard care with general practitioner and/or outpatient clinics OTHER

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/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.

Standard care with general practitioner and/or outpatient clinics

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: collaborator
• Herlev and Gentofte Hospital: collaborator
• Bjorn H. Ebdrup: lead
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (1)

Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup

Glostrup Municipality, Capital Region, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar Disorder; Overweight; Obesity

Interventions

Therapeutics; Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Bipolar and Related Disorders; Mood Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,

  Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup | University of Copenhagen

  STUDY CHAIR

Central Study Contacts

Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,

CONTACT

+4538640840; bjoern.ebdrup@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, consultant, PhD and clinical professor in psychiatry Bjørn Hylsebeck Ebdrup

Model Details: Pragmatic, open label, non-blinded randomized controlled trial

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: October 3, 2024
• Study Start: October 10, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)