Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial
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. Glucag...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-03-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/3/e077173.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849717299828752384 |
|---|---|
| author | Peter Haulund Gæde Jan Frystyk Niels Bilenberg Ashok Ainkaran Ganeshalingam Nicolai Gundtoft Uhrenholt Sidse Arnfred |
| author_facet | Peter Haulund Gæde Jan Frystyk Niels Bilenberg Ashok Ainkaran Ganeshalingam Nicolai Gundtoft Uhrenholt Sidse Arnfred |
| author_sort | Peter Haulund Gæde |
| collection | DOAJ |
| description | 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/m2 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. |
| format | Article |
| id | doaj-art-c9ba5d73654f4d6693ce8ff8b125e7ec |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c9ba5d73654f4d6693ce8ff8b125e7ec2025-08-20T03:12:42ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-077173Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trialPeter Haulund Gæde0Jan Frystyk1Niels Bilenberg2Ashok Ainkaran Ganeshalingam3Nicolai Gundtoft Uhrenholt4Sidse Arnfred52 Department of Cardiology and Endocrinology, Slagelse Hospital, Slagelse, DenmarkEndocrine Research Unit, Department of Endocrinology, Odense University Hospital & Department of Clinical Research, Faculty of Health, Odense Universitetshospital, Odense, Denmark2 Research unit of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark, Odense, DenmarkEndocrine Research Unit, Department of Endocrinology, Odense University Hospital & Department of Clinical Research, Faculty of Health, Odense Universitetshospital, Odense, DenmarkPsychiatry West, Region Zealand, Research Unit West, Slagelse, Denmark, Slagelse, DenmarkUniversity of Copenhagen, Kobenhavn, DenmarkIntroduction 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/m2 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.https://bmjopen.bmj.com/content/14/3/e077173.full |
| spellingShingle | Peter Haulund Gæde Jan Frystyk Niels Bilenberg Ashok Ainkaran Ganeshalingam Nicolai Gundtoft Uhrenholt Sidse Arnfred Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial BMJ Open |
| title | Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial |
| title_full | Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial |
| title_fullStr | Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial |
| title_full_unstemmed | Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial |
| title_short | Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial |
| title_sort | home based intervention with semaglutide treatment of neuroleptic related prediabetes histori protocol describing a prospective randomised placebo controlled and double blinded multicentre trial |
| url | https://bmjopen.bmj.com/content/14/3/e077173.full |
| work_keys_str_mv | AT peterhaulundgæde homebasedinterventionwithsemaglutidetreatmentofneurolepticrelatedprediabeteshistoriprotocoldescribingaprospectiverandomisedplacebocontrolledanddoubleblindedmulticentretrial AT janfrystyk homebasedinterventionwithsemaglutidetreatmentofneurolepticrelatedprediabeteshistoriprotocoldescribingaprospectiverandomisedplacebocontrolledanddoubleblindedmulticentretrial AT nielsbilenberg homebasedinterventionwithsemaglutidetreatmentofneurolepticrelatedprediabeteshistoriprotocoldescribingaprospectiverandomisedplacebocontrolledanddoubleblindedmulticentretrial AT ashokainkaranganeshalingam homebasedinterventionwithsemaglutidetreatmentofneurolepticrelatedprediabeteshistoriprotocoldescribingaprospectiverandomisedplacebocontrolledanddoubleblindedmulticentretrial AT nicolaigundtoftuhrenholt homebasedinterventionwithsemaglutidetreatmentofneurolepticrelatedprediabeteshistoriprotocoldescribingaprospectiverandomisedplacebocontrolledanddoubleblindedmulticentretrial AT sidsearnfred homebasedinterventionwithsemaglutidetreatmentofneurolepticrelatedprediabeteshistoriprotocoldescribingaprospectiverandomisedplacebocontrolledanddoubleblindedmulticentretrial |