背景:BIPCOM旨在(1)确定双相情感障碍(BD)患者的医疗合并症;(2)检查该临床组中医疗合并症(MC)的危险因素和临床概况,特别关注代谢综合征(MetS);(3)开发临床支持工具(CST),用于个性化管理BD和医疗合并症。
方法:BIPCOM项目旨在研究MC,特别是MetS,在患有BD的个体中使用各种方法。最初,患病率,特点,遗传和非遗传危险因素,并且将通过分析北欧注册来评估BD患者中MetS的自然进展,生物银行,以及来自5个国家的11个欧洲招募中心的现有患者数据集。随后,我们将进行一项涉及来自这些中心的400名参与者的临床研究,以检查超过1年的特定MetS危险因素的临床概况和发生率.基线评估,1年随访,生物标志物分析,以及使用可穿戴生物传感器进行身体活动测量,和焦点小组将被执行。利用这些全面的数据,将发展科技委以加强预防,早期发现,以及BD中MC的个性化治疗,通过结合临床,生物,性别和遗传信息。该协议将突出研究的方法。
结论:BIPCOM的数据收集将为BD患者量身定制的治疗和预防方法铺平道路。这种方法有可能通过预防并发症来节省大量的医疗保健。住院治疗,以及与BD合并症和心血管风险相关的紧急就诊。BIPCOM的数据收集将通过个性化策略增强BD患者护理,从而提高了生活质量并减少了昂贵的干预措施。这项研究的结果将有助于更好地理解医疗合并症与BD之间的关系,能够准确预测和有效管理MetS和心血管疾病。
背景:位于https://www的ISRCTN68010602。isrctn.com/ISRCTN68010602.注册日期:2023年4月18日。
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.
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.
BACKGROUND: ISRCTN68010602 at https://www.isrctn.com/ISRCTN68010602 . Registration date: 18/04/2023.