THE BIPCOM PROJECT

Background:

Bipolar Disorder (BD) is a complex and recurrent genetic disorder that varies widely in its clinical presentation and aetiology. It is considered a major public health concern due to its high prevalence, chronic nature, and high degree of disability. BD is also associated with premature mortality, with life expectancy shortened by 10-20 years. Medical comorbidities (MC), including type 2 diabetes, cardiovascular disease (CVD), musculoskeletal disorders, renal disorders, neurological conditions, endocrine pathologies, and metabolic syndrome (MetS), are common among BD patients.

Metabolic syndrome (MetS) is a cluster of metabolic abnormalities that occur together and increase the risk of developing cardiovascular disease, stroke, and type 2 diabetes. MetS is characterized by a group of risk factors that are linked to obesity, insulin resistance, and inflammation. The specific criteria used to diagnose MetS vary, but they typically include a combination of the following:

Diagnostic Criteria for Mets

Values

Waist Circumference 

>102 cm (M); >88 cm (F)

Fasting Glucose

>100 mg/dL 

Blood Pressure

>130/85 mmHg

Triglycerides

>150 mg/dL 

Hdl Cholesterol

<40 mg/dL (M); <50 mg/dL (F)
These comorbidities, including MetS, are caused by a combination of factors such as unhealthy lifestyle choices, insufficient utilization of healthcare services, adverse effects of drug treatments, genetic vulnerability, and high prevalence of substance use disorder. The prevalence of MetS is particularly high in patients with BD and is associated with an increased risk of unfavourable medical outcomes. Physical activity, including light, moderate-vigorous, and sedentary activity, is a significant risk factor for MetS and needs specific investigations. Recent advances in portable sensor technologies, particularly wearable biosensors, have provided important tools to assess daily real-life physical activity accurately.

Aims:

The BIPCOM project aims to achieve three objectives. The first objective is to identify the prevalence rates, characteristics, genetic and non-genetic risk and protective factors, and natural history of Metabolic Syndrome (MetS) among people with BD through the analysis of Nordic registers and biobanks, as well as a cross-sectional study that utilizes existing patient datasets. The second objective is to conduct an Exploratory Clinical Study (ECS) involving 400 subjects recruited from five different sites. The study will focus on examining the clinical profile of participants and the incidence of specific risk factors for MetS onset over one year. The third objective is to develop a Clinical Support Tool (CST) that will facilitate the prevention, early detection, and personalized treatment of medical comorbidities associated with BD. This will involve combining clinical, biological, and genetic data to improve prediction accuracy and inform targeted interventions. Gender-related differences in the prevalence, course, and outcome of medical comorbidities will also be taken into consideration.

The Work Packages:

WORK PACKAGES (WPS)

WP1

Project management            

Leader Project Coordinator- Italy

WP2

Model training and internal validation: register and genetic study

Leader Partner 2 – Sweden

WP3

External validation: a study of real-world risk factors 

 

Leader Partner 1 – Germany

WP4

Exploratory Clinical Study for updating and refining 

Leader Partner 4 – France

WP5

Precision Medicine tool development and implementation        

Leader Partner 3 – Norway

WP6

Involvement and participation of stakeholders 

Leader Project Coordinator- Italy

WP7

Dissemination, Public engagement and Exploitation

Leader Project Coordinator- Italy

Duration:

36 months
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