Medical comorbidities in bipolar disorder (BIPCOM): clinical validation of risk factors and biomarkers to improve prevention and treatment. Study protocol.
Bipolar disorder
Medical comorbidities
Metabolic syndrome
Precision medicine
Quality of life
Journal
International journal of bipolar disorders
ISSN: 2194-7511
Titre abrégé: Int J Bipolar Disord
Pays: Germany
ID NLM: 101622983
Informations de publication
Date de publication:
04 May 2024
04 May 2024
Historique:
received:
07
12
2023
accepted:
24
04
2024
medline:
5
5
2024
pubmed:
5
5
2024
entrez:
4
5
2024
Statut:
epublish
Résumé
BIPCOM aims to (1) identify medical comorbidities in people with bipolar disorder (BD); (2) examine risk factors and clinical profiles of Medical Comorbidities (MC) in this clinical group, with a special focus on Metabolic Syndrome (MetS); (3) develop a Clinical Support Tool (CST) for the personalized management of BD and medical comorbidities. The BIPCOM project aims to investigate MC, specifically MetS, in individuals with BD using various approaches. Initially, prevalence rates, characteristics, genetic and non-genetic risk factors, and the natural progression of MetS among individuals with BD will be assessed by analysing Nordic registers, biobanks, and existing patient datasets from 11 European recruiting centres across 5 countries. Subsequently, a clinical study involving 400 participants from these sites will be conducted to examine the clinical profiles and incidence of specific MetS risk factors over 1 year. Baseline assessments, 1-year follow-ups, biomarker analyses, and physical activity measurements with wearable biosensors, and focus groups will be performed. Using this comprehensive data, a CST will be developed to enhance the prevention, early detection, and personalized treatment of MC in BD, by incorporating clinical, biological, sex and genetic information. This protocol will highlight the study's methodology. BIPCOM's data collection will pave the way for tailored treatment and prevention approaches for individuals with BD. This approach has the potential to generate significant healthcare savings by preventing complications, hospitalizations, and emergency visits related to comorbidities and cardiovascular risks in BD. BIPCOM's data collection will enhance BD patient care through personalized strategies, resulting in improved quality of life and reduced costly interventions. The findings of the study will contribute to a better understanding of the relationship between medical comorbidities and BD, enabling accurate prediction and effective management of MetS and cardiovascular diseases. ISRCTN68010602 at https://www.isrctn.com/ISRCTN68010602 . Registration date: 18/04/2023.
Sections du résumé
BACKGROUND
BACKGROUND
BIPCOM aims to (1) identify medical comorbidities in people with bipolar disorder (BD); (2) examine risk factors and clinical profiles of Medical Comorbidities (MC) in this clinical group, with a special focus on Metabolic Syndrome (MetS); (3) develop a Clinical Support Tool (CST) for the personalized management of BD and medical comorbidities.
METHODS
METHODS
The BIPCOM project aims to investigate MC, specifically MetS, in individuals with BD using various approaches. Initially, prevalence rates, characteristics, genetic and non-genetic risk factors, and the natural progression of MetS among individuals with BD will be assessed by analysing Nordic registers, biobanks, and existing patient datasets from 11 European recruiting centres across 5 countries. Subsequently, a clinical study involving 400 participants from these sites will be conducted to examine the clinical profiles and incidence of specific MetS risk factors over 1 year. Baseline assessments, 1-year follow-ups, biomarker analyses, and physical activity measurements with wearable biosensors, and focus groups will be performed. Using this comprehensive data, a CST will be developed to enhance the prevention, early detection, and personalized treatment of MC in BD, by incorporating clinical, biological, sex and genetic information. This protocol will highlight the study's methodology.
DISCUSSION
CONCLUSIONS
BIPCOM's data collection will pave the way for tailored treatment and prevention approaches for individuals with BD. This approach has the potential to generate significant healthcare savings by preventing complications, hospitalizations, and emergency visits related to comorbidities and cardiovascular risks in BD. BIPCOM's data collection will enhance BD patient care through personalized strategies, resulting in improved quality of life and reduced costly interventions. The findings of the study will contribute to a better understanding of the relationship between medical comorbidities and BD, enabling accurate prediction and effective management of MetS and cardiovascular diseases.
TRIAL REGISTRATION
BACKGROUND
ISRCTN68010602 at https://www.isrctn.com/ISRCTN68010602 . Registration date: 18/04/2023.
Identifiants
pubmed: 38703295
doi: 10.1186/s40345-024-00337-8
pii: 10.1186/s40345-024-00337-8
doi:
Types de publication
Journal Article
Langues
eng
Pagination
15Subventions
Organisme : Fondazione Regionale per la Ricerca Biomedica (Italy)
ID : ERAPERMED2022-087
Organisme : Norges Forskningsråd
ID : ERAPERMED2022-087
Organisme : Sächsisches Staatsministerium für Wissenschaft und Kunst
ID : ERAPERMED2022-087
Organisme : Departament de Salut, Generalitat de Catalunya
ID : ERAPERMED2022-087
Organisme : Sweden's Innovation Agency (VINNOVA)
ID : ERAPERMED2022-087
Organisme : Agence Nationale de la Recherche
ID : ERAPERMED2022-087
Organisme : German Federal Ministry of Education and Research (BMBF)
ID : ERAPERMED2022-087
Investigateurs
Maximilian Bayas
(M)
Frank Bellivier
(F)
Narcís Cardoner Álvarez
(NC)
Pietro Carmellini
(P)
Federico Cevoli
(F)
Julia Clemens
(J)
Philippe Courtet
(P)
Lorena Consoli
(L)
Giuseppe Delvecchio
(G)
Maja Dobrosavljevic
(M)
Bruno Etain
(B)
Hendrik Friedrichsen
(H)
Adrienne Kelemen
(A)
Despoina Koukouna
(D)
Eugenia Mato
(E)
Dídac Mauricio
(D)
Romina Miranda-Olivos
(R)
Lisa Möbius
(L)
Chiara Moltrasio
(C)
Caroline Mohn-Haugen
(C)
Isabelle Nuss
(I)
Emilie Olie
(E)
Agnes Pelletier
(A)
Zillur Rahman
(Z)
Davide Rampi
(D)
Jonathan Repple
(J)
Eugenia Resmini
(E)
Julia Schneider
(J)
Elena Toffol
(E)
Informations de copyright
© 2024. The Author(s).
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