双相情感障碍的医学共病（BIPCOM）：改善预防和治疗的风险因素及生物标志物的临床验证。研究方案。
Medical comorbidities in bipolar disorder (BIPCOM): clinical validation of risk factors and biomarkers to improve prevention and treatment. Study protocol.
作者信息
de Girolamo Giovanni, Andreassen Ole A, Bauer Michael, Brambilla Paolo, Calza Stefano, Citerà Nicholas, Corcoy Rosa, Fagiolini Andrea, Garcia-Argibay Miguel, Godin Ophélia, Klingler Florian, Kobayashi Nene F, Larsson Henrik, Leboyer Marion, Matura Silke, Martinelli Alessandra, De la Peña-Arteaga Víctor, Poli Roberto, Reif Andreas, Ritter Philipp, Rødevand Linn N, Magno Marta, Caselani Elisa
机构信息
Unit of Epidemiological and Evaluation Psychiatry, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Norwegian Center for Mental Disorders Research (NORMENT), Division of Mental Health and Addiction, Institute of Clinical Medicine, Oslo University Hospital, University of Oslo, Oslo, Norway.
出版信息
Int J Bipolar Disord. 2024 May 4;12(1):15. doi: 10.1186/s40345-024-00337-8.
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
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
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
ISRCTN68010602 at https://www.isrctn.com/ISRCTN68010602 . Registration date: 18/04/2023.
背景
双相情感障碍综合医疗项目（BIPCOM）旨在：（1）识别双相情感障碍（BD）患者的合并症；（2）研究该临床群体中合并症（MC）的危险因素和临床特征，特别关注代谢综合征（MetS）；（3）开发一种临床支持工具（CST），用于双相情感障碍及合并症的个性化管理。
方法
BIPCOM项目旨在通过多种方法研究双相情感障碍患者的合并症，特别是代谢综合征。首先，将通过分析来自5个国家11个欧洲招募中心的北欧登记册、生物样本库和现有患者数据集，评估双相情感障碍患者中代谢综合征的患病率、特征、遗传和非遗传危险因素以及自然病程。随后，将对来自这些地点的400名参与者进行一项临床研究，以检查特定代谢综合征危险因素在1年中的临床特征和发病率。将进行基线评估、1年随访、生物标志物分析、使用可穿戴生物传感器进行身体活动测量以及焦点小组讨论。利用这些全面的数据，将开发一种临床支持工具，通过纳入临床、生物学、性别和遗传信息，加强双相情感障碍合并症的预防、早期检测和个性化治疗。本方案将突出该研究的方法。
讨论
BIPCOM的数据收集将为双相情感障碍患者量身定制治疗和预防方法铺平道路。这种方法有可能通过预防与双相情感障碍合并症和心血管风险相关的并发症、住院和急诊就诊，节省大量医疗费用。BIPCOM的数据收集将通过个性化策略加强双相情感障碍患者的护理，从而提高生活质量并减少昂贵的干预措施。该研究的结果将有助于更好地理解合并症与双相情感障碍之间的关系，从而能够准确预测和有效管理代谢综合征和心血管疾病。
试验注册
https://www.isrctn.com/ISRCTN68010602上的ISRCTN68010602。注册日期：2023年4月18日。
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