Medical comorbidities in bipolar disorder (BIPCOM) : clinical validation of risk factors and biomarkers to improve prevention and treatment. Study protocol.

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 accura
Study Protocol.Funded by the Joint Transnational Call for Proposals (JTC) 2022 on "Prevention in Personalised Medicine " within the framework of ERA PerMed, ERAPERMED2022-087—BIPCOM. This project was supported by: 1. Fondazione Regionale per la Ricerca Biomedica (Italy); 2. Bundesministerium für Bildung und Forschung (Germany); 3. VINNOVA (Sweden); 4. Norges Forskningsråd (Norway); 5. Agence Nationale de la Recherche (France); 6. Departament de Salut, Generalitat de Catalunya (Spain); 7. Sächsisches Staatsministerium für Wissenschaft und Kunst (Germany); under the frame of ERA PerMed.