Abstract
Introduction Subjects with schizophrenia have a 2-3 fold higher mortality rate than the general population and a reduced life expectancy of 10-20 years. Approximately one-third of this excess mortality has been attributed to obesity-related type 2 diabetes (T2D) and to cardiovascular disease. Glucagon-like peptide-1 (GLP-1) analogues increase satiety and delay gastric emptying, thereby reducing food intake and weight. GLP-1 analogues also exert beneficial effects on cardiovascular outcomes in high-risk patients with T2D. Our aim is to investigate whether 30 weeks add-on treatment with the GLP-1 analogue semaglutide can reduce HbA1c sufficiently to reverse pre-diabetes and the metabolic syndrome in overweight schizophrenic patients. Methods and analysis We will perform a 30 week, two-armed, multicentre, superiority, double-blinded, randomised trial investigating the effect of weekly injections of semaglutide versus placebo in mental health facilities in Region of Southern Denmark and Region of Zealand, Denmark. In total, 154 adults with schizophrenia spectrum disease, aged 18-60 years treated with second generation antipsychotic treatment, HbA1c 39-47 mmol/mol and body mass index >27 kg/m 2 will be randomised to injections of 1.0 mg semaglutide or placebo. The primary outcome is changes in HbA1c. Secondary outcomes encompass metabolic measures, psychotic symptoms and quality of life. Exploratory outcomes encompass insulin sensitivity, cardiovascular risk profile, medication adherence, general well-being and physical activity. Ethics and dissemination This study will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. This research has obtained approval from both the Danish Medicines Agency and The Regional Committees on Health Research Ethics for Southern Denmark. Trial registration number NCT05193578 European Clinical Trials Database Number (EudraCT) 2020-004374-22, Regional Ethical Committee number S-20200182.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | e077173 |
| Tidsskrift | BMJ Open |
| Vol/bind | 14 |
| Udgave nummer | 3 |
| Antal sider | 9 |
| ISSN | 2044-6055 |
| DOI | |
| Status | Udgivet - 2024 |
Bibliografisk note
Funding Information:Novo Nordisk Foundation: DKK8 584 959 (salary and tuition fee PHD Students and study-nurses, running expenses, biochemical and laboratory procedures, TAP personal, mileage allowance). Research Grant from Steno Diabetes Center Zealand, Denmark: DKK660 000. Research Grant from Steno Diabetes Center Odense, Denmark: DKK578 000. Annum (Region Zealand) to PhD-student Nicolai Uhrenholt: DDK20 000 per year for 3 years (DKK60 000 in total). Slagelse Puljen 2020: The Region of Zealand, Denmark: DKK240 000. Slagelse Puljen 2022: DKK150 000 DKK. Region Sjællands Sundhedsvidenskabelige Forskningsfond 2022: DKK252 631. Furthermore, Novo Nordisk A/S will provide investigational drug and placebo free of charge for sponsor, but is otherwise not involved in the study. The scientists involved will conduct the experiment out of general scientific interest without personal financial gain. None of the investigators involved have financial interests (including shares, direct employment, members of advisory boards) in the drug company that produces the active drug used in the study. None of the participants in the study will receive any provision for participation. Participants will receive mileage allowances. Any harm as a result of study participation will be covered by the Danish Patient Compensation.
Publisher Copyright:
© 2024 Archives of Disease in Childhood. All rights reserved.