Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The… (NCT06624462) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Denmark84 participantsStarted 2023-10-10
Plain-language summary
This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
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 judg…
What they're measuring
1
Proportion of patients achieving a weight loss of ≥5% of initial body weight.