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NCT06624462Recruiting

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

Source: ClinicalTrials.gov · Last updated 8 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
84 (estimated)
First submitted
4 Sept 2024
Start date
10 Oct 2023
Primary completion date
Dec 2026
Lead sponsor
Bjorn H. Ebdrup
NCT number
NCT06624462

What you commit to

  • Study type: Interventional
  • Planned participants: 84
  • From 10 Oct 2023 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe current drug or alcohol misuse as judged by the research team.

Other illness

  • Unstable psychiatric disorder as judged by the research team.

Lab values

  • Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team.

Other

  • Acute suicidal risk.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup
Coordinator of this site? Confirm its status
Glostrup MunicipalityDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.